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EMEA Translational Science R&D Sr Scientist

Ansök    Dec 19    Mcneil AB    Forskare, farmakologi
Kenvue is currently recruiting for: Sr Scientist EMEA Translational Science R&D This position reports to Director EMEA Translational Science R&D and is based in Helsingborg, Sweden. Who we are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands — including OTC brands such as NICORETTE®, IPREN®, LIVOSTIN®, IMODIUM®, PEPCID® and consumer health brands li... Visa mer
Kenvue is currently recruiting for:
Sr Scientist EMEA Translational Science R&D
This position reports to Director EMEA Translational Science R&D and is based in Helsingborg, Sweden.
Who we are
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands — including OTC brands such as NICORETTE®, IPREN®, LIVOSTIN®, IMODIUM®, PEPCID® and consumer health brands like NEUTROGENA®, LISTERINE®, NATUSAN®, PIZ BUIN® and o.b. ®. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.
The Kenvue site in Helsingborg, Sweden is the home of the strong and growing brand NICORETTE®, a global market leader in smoking cessation. In 2021 our production facility was recognized as a Lighthouse by World Economic Forum, marking us as a beacon in The Fourth Industrial Revolution.
The Helsingborg site is one of the largest employers in the city of Helsingborg, and the business is divided in two separate departments: Operations, where we house our manufacturing activities and R & D, our global development center for excellence working in three therapeutic areas for selfcare treatments: Smoking Cessation, Digestive Health and Cough & Cold. For more information, click here


What you will do
The Sr Scientist, EMEA Translational Science R&D serves as a consumer and clinical strategy lead for innovation or renovation projects across all consumer health categories, with a primary focus on Cough and Cold. The role involves significant collaboration across many different functions within Kenvue. This position will, in close collaboration with cross functional partners, evaluate innovation opportunities, lead the creation of a fit for purpose end-to-end consumer learning plan and execute defined studies.
This position will specifically have responsibility in creating consumer research strategies, planning research, act as study manager and report the outcome of such studies to project teams, stake holders and management.
This role involves extensive cross-functional and global/cross-regional team matrix interactions
Key Responsibilities:
Responsible for designing consumer research studies in partnership with selected vendors and Kenvue cross functional teams
Act as study manager and lead cross functional teams to assure studies are executed as per plan and company procedures
Apply owners mindset by constantly looking for opportunities to strengthen and accelerate study methodology, protocol design and execution models
Represent Translational Science (across consumer and clinical research) in the cough and cold need state development team
Assure appropriate claims and consumer learning plans are developed for EMEA lead product innovation and major renovation projects
Partner closely with Consumer Business Intelligence, Product Design and Commercial teams to assure alignment of study objectives and plans
Partner with regulatory and medical affairs to assure plans meets regulatory and relevant industry association requirements
Engage with senior management, the wider translational science community and brand teams to share research outcomes
Maintain an outside-in perspective with required credible partnerships to assure that we continue to advance our capabilities with improved and new methodologies to help drive stronger claims, higher quality studies, as well as faster and more cost effective execution



What we are looking for
Required Qualifications
Bachelor's degree with at least 5+ years or Master’s degree with 3+ years of relevant work experience in consumer self-care (OTC, Medical devices and Food supplements) product development, design and consumer research
Proven experience of consumer research for the OTC medicine category
Experience of consumer research from other consumer health categories (e.g. cosmetics, hair care)
Experience from partnering and leading research with consumer research agencies
Experience in OTC medicine product development and analytical testing
Must have experience of leading project teams as well as strong skills in collaboration, communication, leadership and ability to effectively explain scientific concepts.
Candidates need to be proficient with Microsoft Office, Word, Excel, and PowerPoint and have strong oral and written communication skills in English.
R&D experience from the Cough and Cold OTC category
Experience from working with products in multiple regulatory classifications (food supplements, OTC medicines, cosmetics,…)
Have an understanding of consumer brand fundamentals


What’s in it for you
Competitive Total Rewards Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Employee Resource Groups


Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.
Background checks in the recruitment process
As a final candidate in our recruitment process, you may be subject to a background check. This process is important for us to ensure the quality of our recruitment process.
As part of this, it is important that we encourage you to make sure that the information in your CV is correct before submitting your application to us.
To carry out these background checks, we use a background check company. Different checks may be carried depending on the position that you are applying for. This could be, for example:
Reference checks
CV-validation
Financial checks
Litigation checks, including criminal cases



The background check company is an independent data controller for any personal data that they will process during the check, and if you have any questions about the processing, you may turn to the background check company.
Due to our business activities and daily operations, we may also carry out drug tests as part of our recruitment process. Visa mindre

Sr Scientist - EMEA Translational Science R&D

Ansök    Okt 29    Mcneil AB    Forskare, farmakologi
Kenvue is currently recruiting for: Sr Scientist - EMEA Translational Science R&D This position reports to Director EMEA Translational Science R&D and is based in Helsingborg, Sweden. Who we are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands — including OTC brands such as NICORETTE®, IPREN®, LIVOSTIN®, IMODIUM®, PEPCID® and consumer health brands l... Visa mer
Kenvue is currently recruiting for:
Sr Scientist - EMEA Translational Science R&D
This position reports to Director EMEA Translational Science R&D and is based in Helsingborg, Sweden.
Who we are
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands — including OTC brands such as NICORETTE®, IPREN®, LIVOSTIN®, IMODIUM®, PEPCID® and consumer health brands like NEUTROGENA®, LISTERINE®, NATUSAN®, PIZ BUIN® and o.b. ®. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.

The Kenvue site in Helsingborg, Sweden is the home of the strong and growing brand NICORETTE®, a global market leader in smoking cessation. In 2021 our production facility was recognized as a Lighthouse by World Economic Forum, marking us as a beacon in The Fourth Industrial Revolution.

The Helsingborg site is one of the largest employers in the city of Helsingborg, and the business is divided in two separate departments: Operations, where we house our manufacturing activities and R & D, our global development center for excellence working in three therapeutic areas for selfcare treatments: Smoking Cessation, Digestive Health and Cough & Cold. For more information, click here

What you will do
The Sr Scientist, EMEA Translational Science R&D serves as a consumer and clinical strategy lead for innovation across all consumer health categories, with a primary focus on Cough and Cold. This position works closely with cross-functional teams to evaluate innovation opportunities within their assigned segments, need states or brands and create a fit for purpose end-to-end consumer learning plan for the initiative.
This position will specifically have responsibility in creating consumer research strategies, planning research, act as study manager and report the outcome of such studies to stake holders and management.
This role involves extensive cross-functional and global/cross-regional team matrix interactions.


Key Responsibilities:
Responsible for designing consumer research studies in collaboration with selected vendors and Kenvue cross functional teams
Act as study manager and lead cross functional teams to assure studies are executed as per plan
Apply owner’s mindset by constantly looking for opportunities to strengthen study methodology, protocol design and execution models
Represent Translational Science (across consumer and clinical research) in selected brand development teams
Assure appropriate claims and consumer learning plans are developed for EMEA lead product innovation project
Partner closely with R&D, Consumer Business Intelligence and Commercial teams to assure alignment of study objectives and plans
Partner with regulatory and medical affairs to assure plans meets regulatory requirements
Engage with senior management and brand teams to share research outcomes
Maintain an outside-in perspective with required credible partnerships to assure that we continue to advance our capabilities with improved and new methodologies to help drive stronger claims, higher quality studies, as well as faster and more cost-effective execution

What we are looking for
Required Qualifications
Bachelor's degree with at least 5+ years or Master’s degree with 3+ years of relevant work experience in consumer self-care (OTC, Medical devices and Food supplements) product development, design and consumer research
Proven experience of consumer research for the OTC medicine category
Some level of experience of consumer research from other consumer health categories (e.g. cosmetics, hair care)
Experience from partnering with consumer research agencies
Experience in OTC medicine product development and testing
Must have experience of leading project teams as well as strong skills in collaboration, communication, leadership and ability to effectively explain scientific concepts.
Candidates need to be proficient with Microsoft Office, Word, Excel, and PowerPoint and have strong oral and written communication skills in English.
R&D experience from the Cough and Cold OTC category
Experience from working with products in multiple regulatory classifications (food supplements, OTC medicines, cosmetics,…)
Have an understanding of consumer brand fundamentals



What’s in it for you
Competitive Total Rewards Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Employee Resource Groups Visa mindre

Senior Packaging Engineer

Ansök    Nov 29    QRIOS Minds AB    Forskare, farmakologi
About the position We are looking for an Senior Packaging Engineer for 1 full year assignment or longer at our customer in the medtech industry in Helsingborg. The right candidate will provide SME packaging support to multi-functional team, lead the packaging scope, both new product development and existing products (life cycle management) Responsibilities Essential duties and responsibilities: • Technical expert within the multi-functional team. • Manage... Visa mer
About the position
We are looking for an Senior Packaging Engineer for 1 full year assignment or longer at our customer in the medtech industry in Helsingborg.
The right candidate will provide SME packaging support to multi-functional team, lead the packaging scope, both new product development and existing products (life cycle management)

Responsibilities
Essential duties and responsibilities:
• Technical expert within the multi-functional team.
• Management and coordination of packaging projects, directly or under supervision
• Definition and follow-up of technical schedules
• Due diligence/gap assessment activity related to packaging
• Definition and follow-up of packaging qualifications
• Creation of associated documentation to authorize the marketing of products (specifications, qualification plan, qualification report, technical specifications) in collaboration with internal and external partners and updating of internal systems
• Risk assessment, remediation plan and communication in the context of program management
• Coordination and follow-up of manufacturing line tests with internal and external sites

Your profile
Essential knowledge and skills:
- Packaging development expertise
- Knowledge of packaging processes in the pharmaceutical industry (packaging technologies, manufacturing, regulatory affairs, drug knowledge, etc)
- Fluent English
- Parallel management of numerous projects and stakeholders.
- Leadership and good communication skills
- Curiosity and creativity
- Organizational skills and ability to manage complex issues in a matrix organization
Core competencies required for this role:
- Packaging development expertise
- Parallel management of numerous projects and stakeholders.
- Independent, leadership and good communication skills

About the organisation
This is a consultant assignment for one year at our customer in Helsingborg. During this time you will be hired by QRIOS.

QRIOS Life Science & Engineering can offer several opportunities for skilled people with a background in the filed of science and engineering. Ee work with Sweden’s leading pharmaceutical and engineering companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at QRIOS gives you opportunities to try different industries, companies and roles.

It suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant. Visa mindre

Senior Scientist

Ansök    Nov 23    QRIOS Minds AB    Forskare, farmakologi
About the position The responsibilities of Product Design (PD) in Helsingborg are to develop products for the customer's self-care global and regional product portfolio. PD is responsible for early prototyping, formulation, manufacturing of clinical batches, tech transfer to manufacturing sites as well as documentation to support regulatory submission. The Product Design team is now evolving and broadening the skillsets beyond formulation development and t... Visa mer
About the position
The responsibilities of Product Design (PD) in Helsingborg are to develop products for the customer's self-care global and regional product portfolio. PD is responsible for early prototyping, formulation, manufacturing of clinical batches, tech transfer to manufacturing sites as well as documentation to support regulatory submission. The Product Design team is now evolving and broadening the skillsets beyond formulation development and to further increase external based R&D partnerships. This necessitates R&D technical project management skills and to be able to manage external relationsships. We are now looking for a Senior Scientist (PG25) for a temporary position until November 2023 to the C&C and Digestive Health team, where all R&D formulation development will be done with external development partners.

Responsibilities
• As formulation lead, drive formulation development activities together with external based R&D development partners.
• As R&D Team lead, drive R&D execution through building time plans, escalating major issues and deviations from plan, risk management, driving immediate problem solving and aggressively progress key milestones.
• Collaborate with quality, medical/ safety, and regulatory to ensure targeted solutions meet applicable standards.
• Report R&D progress into the NPD core team.
• Potential international travel up to 5% time to ensure robust formulation development work.

Your profile
• Bachelor’s degree with at least 4 years or Master’s degree with 2 years of relevant work experience in consumer self-care (OTC) product development or design.
• Tech transfer experience & experience working with external partners preferred.
• Demonstrated collaboration and leadership skills to be able to coordinate and drive the formulation development work with external development partners and other team environments.
• Knowledge and experience in working in accordance of GMP as well as within biopharmaceutical aspects and regulatory requirements.
• Demonstrated intellectual curiosity and a creative problem solver.
• Must have the ability to work individually (independently) as well as on a team.
• Candidates need to be proficient with Microsoft Office, Word, Excel, and PowerPoint and have strong oral and written communication skills in English.
• Candidates must be legally authorized to work in the European Union and not require sponsorship for employment visa status now or in the future.


About the organisation
This is a consultant assignment until November 2023 at our customer in Helsingborg. During this time you will be hired by QRIOS.

QRIOS Life Science & Engineering can offer several opportunities for skilled people with a background in the filed of science and engineering. Ee work with Sweden’s leading pharmaceutical and engineering companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at QRIOS gives you opportunities to try different industries, companies and roles.

It suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant. Visa mindre

Laboratory Engineer

Ansök    Sep 21    QRIOS Minds AB    Forskare, farmakologi
About the position Are you an experienced scientist that is looking for a new challenge? Do you have experience in GMP, Pharmacopeia experience and working in lab? If yes you might be the one we are looking for! This is a consultant assignment with an initial duration of 6 months at our customer that is a med-tech company in Helsingborg. During the assignment you will be hired byt QRIOS. We look forward receiving your application! Responsibilities • Pe... Visa mer
About the position
Are you an experienced scientist that is looking for a new challenge? Do you have experience in GMP, Pharmacopeia experience and working in lab?
If yes you might be the one we are looking for!

This is a consultant assignment with an initial duration of 6 months at our customer that is a med-tech company in Helsingborg. During the assignment you will be hired byt QRIOS.
We look forward receiving your application!

Responsibilities
• Performing analyzes on raw materials according to current pharmacopoeias (EP, USP/NF, JP, ChP).
• Daily lab work


Your profile
• Life science or engineering education
• Swedish and/or English
• Computer & System knowledge (Labware LIMS).
• Easy to learn
• Positive mindset and attitude
• Good communication skills
• Sense of urgency: ability to proactively sense and act on problems and opportunities and a willingness to act quickly

About the organisation
This is a consultant assignment at our customer in Helsingborg for 6 months to start with. During this time you will be hired by us at QRIOS.

QRIOS Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at QRIOS gives you opportunities to try different industries, companies and roles. Visa mindre

R&D Scientist – Analytical Development

Ansök    Mar 8    Qrios Minds AB    Forskare, farmakologi
Are you an experienced scientist that is lookig for a new challenge? Do you have experience in GMP and analytical chemistry? If yes you might be the one we are looking for! This is a consultant assignment with an initial duration of 9 months at our customer in Helsingborg. During the assignment you will be hired byt QRIOS! We look forward receiving your application as soon as possible. About the position The analytical scientist will work within the An... Visa mer
Are you an experienced scientist that is lookig for a new challenge? Do you have experience in GMP and analytical chemistry?
If yes you might be the one we are looking for!

This is a consultant assignment with an initial duration of 9 months at our customer in Helsingborg. During the assignment you will be hired byt QRIOS!
We look forward receiving your application as soon as possible.

About the position
The analytical scientist will work within the Analytical Life Cycle Management section and support marketed OTC products primarily within EMEA/APAC but also globally. You will be in a regional team of 7 analytical colleagues.
Together with your colleagues you will provide analytical support for a series of projects associated with the currently marketed OTC products. Technical support will include but not be limited to; analytical support to product development, test method development and improvement, test method validation as well as test method transfers. Most of the laboratory work is performed using analytical techniques such as UPLC, HPLC and GC. The technical support will also include desktop related work such as performing and reporting analytical test method gap assessments


Responsibilities
• Laboratory work including development support, method development and improvement, validation and transfers
• Performing and reporting analytical gap assessments
• Collaborate with local R&D stakeholders such as Product Design, QA, Franchise, Regulatory, CMC and others to ensure flawless completion of the activities.

Your profile
• Minimum of BSc within a relevant chemistry or pharmaceutical area
• A minimum of 5 years in an analytical laboratory role supporting pharmaceutical manufacturing or product development with a major emphasis on product testing with analytical method development, optimization, validation, verification, transfer skills as an added bonus.
• Experience and deep knowledge with the chromatography system Empower as well as HPLC/UPLC, GC, dissolution and other major analytical techniques
• Comprehensive understanding of quality and regulatory compliance knowledge, pharmacopeia including USP, EP, ICH/WHO guidelines and good understanding of GMP systems
• Technical writing and documentation review abilities
• You need to be an innovative and a creative problem solver who can work independently, while managing multiple priorities successfully. Strong written and oral communication skills (English) are essential.
• Hands on experience from working in a GMP laboratory


About the organisation
Qrios Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at Qrios gives you opportunities to try different industries, companies and roles. Read more about how it is to be a consultant through us: https://www.qrios.se/karriar/tips/konsult/.

It suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant. Visa mindre

QA specialist

Ansök    Maj 23    Qrios Minds AB    Forskare, farmakologi
About the position Are you an experienced scientist that is looking for a new challenge? Do you have experience in GMP and a scientific background? If yes you might be the one we are looking for! Our customer is searching for the rignt candidate to work as a QA specialist. This is a consultant assignment with an initial duration of 7 months at our customer in Helsingborg. During the assignment you will be hired byt QRIOS! We look forward receiving your ... Visa mer
About the position
Are you an experienced scientist that is looking for a new challenge? Do you have experience in GMP and a scientific background?
If yes you might be the one we are looking for! Our customer is searching for the rignt candidate to work as a QA specialist.

This is a consultant assignment with an initial duration of 7 months at our customer in Helsingborg. During the assignment you will be hired byt QRIOS!
We look forward receiving your application as soon as possible.



Responsibilities
• QP release of finished goods to the market
• Certificates of Analysis
• Assess quality deviations and approve investigations
• QA support to production


Your profile
• A degree in pharmacy or natural sciences of at least 160 p (according to the old system) or 240 p (according to the new system)
• familiar with GMP and have experience from the pharmaceutical industry
• Language requirement: Swedish and English languages (write, read, and speak)
• Computer & System knowledge (easy to adjust to unfamiliar IT-systems, for example ERP systems, Electronic batch records, automation system).
• Proficient in Microsoft Office (Excel, Word, PowerPoint)
• Easy to learn
• Positive mindset and attitude
• Good communication skills
• Sense of urgency: ability to proactively sense and act on problems and opportunities and a willingness to act quickly. Visa mindre

Acorai AB Clinical researcher

Ansök    Apr 28    Acorai AB    Forskare, farmakologi
Despite innovations in cardiovascular disease early detection and treatment, such as heart attacks and heart failures, costs are still high. We realized that something had to be done, so we founded Acorai in 2019 with the vision of redefining the monitoring and treatment of patients with heart failure through new technology and artificial intelligence. We intend to make monitoring for heart failure easier, more precise, and more affordable. General descrip... Visa mer
Despite innovations in cardiovascular disease early detection and treatment, such as heart attacks and heart failures, costs are still high. We realized that something had to be done, so we founded Acorai in 2019 with the vision of redefining the monitoring and treatment of patients with heart failure through new technology and artificial intelligence. We intend to make monitoring for heart failure easier, more precise, and more affordable.
General description
As a Clinical researcher at Acorai you will play an important role in designing, planning, and reporting research and development studies. You will be responsible for different research/development project.
Main tasks and responsibilities:
· Design and report on research and development test/studies according to project plans.
· Perform data analysis and present results for studies.
· Running and monitoring clinical and pre-clinical trials to become part of the team.
· Communication with clinical sites
· Ensuring good clinical practice compliance from a documentation perspective.
· Conducting site visits,
· Responding to queries from the researchers & regulatory authorities, etc.
· Continuous daily dialogue where we assess the risks and opportunities of the studies.
Requested qualifications:
PhD degree within biotechnology or equivalent
Ability and experience to work with data analysis and statistics.
Experience from designing and conducting project activities and laboratory work.
Proficient with Microsoft Office products.
Excellent in English language, both written and oral.
Experience from work in the industry is a requirement



Öppen för alla
Vi fokuserar på din kompetens, inte dina övriga förutsättningar. Vi är öppna för att anpassa rollen eller arbetsplatsen efter dina behov. Visa mindre

QA Validation Specialist

Ansök    Mar 1    Qrios Minds AB    Forskare, farmakologi
Are you an experienced scientist that lookig for a new challenge? Do you have experience in QA Vallidation and GMP/ cGXP? If yes you might be the one we are looking for! This is a consultant assignment with an initial duration of 2 months at our customer in Helsingborg. We look forward receiving your application as soon as possible. About the position The QA Validation Specialist role is part of the Quality System and Compliance team. In this role yo... Visa mer
Are you an experienced scientist that lookig for a new challenge? Do you have experience in QA Vallidation and GMP/ cGXP? If yes you might be the one we are looking for!

This is a consultant assignment with an initial duration of 2 months at our customer in Helsingborg.
We look forward receiving your application as soon as possible.


About the position
The QA Validation Specialist role is part of the Quality System and Compliance team. In this role you will support validation CSV activities. The position requires knowledge of cGXP, GAMP and associated industry and regulatory guidance document to reviews and approve reports and other sources of information to ensure that validations and procedures are in compliance with current industry, regulatory requirements, and current technology.

Your profile
Requires knowledge in Computer Software Validation
Knowledge of validation and qualification principles, and Quality Systems principles (Change Control, Non-Conformance, CAPA and Risk management) within an API, pharmaceutical, or biotech industry.

Special requirements:
Language requirement: Excellent in English and Swedish (write, read and speak)
Advanced level in Excel
Analytical, self-motivated, energetic and self-disciplined person
Problem solver Fast learner Good communication skills
Attention to detail
Able to work in a high-paced environment

About the organisation
Qrios Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at Qrios gives you opportunities to try different industries, companies and roles. Read more about how it is to be a consultant through us: https://www.qrios.se/karriar/tips/konsult/.

It suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant. Visa mindre

Medical Device specialist - Project Contractor

Ansök    Feb 4    Qrios Minds AB    Forskare, farmakologi
About the position Our customer in Helsingborg is offering a contractor position for someone that can provide leadership and ensure compliance with European in a global project which aims to develop a new medical device product with a software. Support and drive the end-to-end product development from a quality & compliance perspective to enable successful product registration in EMEA and to fulfill applicable European requirements including crafting and a... Visa mer
About the position
Our customer in Helsingborg is offering a contractor position for someone that can provide leadership and ensure compliance with European in a global project which aims to develop a new medical device product with a software. Support and drive the end-to-end product development from a quality & compliance perspective to enable successful product registration in EMEA and to fulfill applicable European requirements including crafting and approving relevant documentation.
Collaborate with various other stakeholders locally, regionally and even globally.
Knowledge of EU Medical Device regulations, previous experience with software development as Medical Devices is a merit/beneficial


Responsibilities
• Drive and ensure full R&D Q&C support in project Apricot
• Experience working in product development projects
• Apply medical device expertise in the project
• Manage related communication to all stakeholders
• Manage product development documentation in a fully compliant manner
• Ensure compliance with regional requirements, and internal J&J requ.
• Provide software development support as per project need.
• Collaborate with stakeholders in the project to ensure flawless completion of the project activities, and accurate and timely reply to stakeholder requests.


Your profile
Education Level: Scientist (Pharmacist, Engineer, Biologist, Chemist, etc.)
Ability to build partnerships internally and externally
Mature leadership skills

Language requirement: Excellent in English and one or more of any of the Nordic (Swedish, Finnish, Norwegian, Danish) languages (write, read and speak)
Advanced level in Excel (mandatory & non-negotiable)
Analytical, structured, self-motivated, energetic and self-disciplined person
Problem solver
Fast learner
Good communication skills
Attention to detail and at the same time ability to understand the big picture
Able to work in a high-paced environment

General understanding of the Medical Devices and Pharma industry and MD registration process
Excellent collaboration skills



About the organisation
This is a consultant assignment at a Pharmaceutical Company in Helsingborg for 40-60% during nine months. During this time you will be hired by QRIOS.

QRIOS Life Science & Engineering can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at QRIOS gives you opportunities to try different industries, companies and roles. Read more about how it is to be a consultant through us: https://www.qrios.se/karriar/tips/konsult/.

It suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant. Visa mindre

Yrkeshygieniker/Kemist

Nu söker vi en yrkeshygieniker/kemist till ett globalt hälsovårdsföretag i södra Sverige. Som yrkeshygieniker/kemist kommer du att arbeta på avdelningen Miljö, Hälsa & Säkerhet i ett företag där arbetsmiljöfrågorna är högt prioriterade. Din viktigaste uppgift är att arbeta förebyggande så att exponeringar och skador undviks. Dina arbetsuppgifter i huvudsak Dina arbetsuppgifter är: • Deltaga i kemiska riskbedömningar samt i projektgrupper • Genomföra ut... Visa mer
Nu söker vi en yrkeshygieniker/kemist till ett globalt hälsovårdsföretag i södra Sverige.
Som yrkeshygieniker/kemist kommer du att arbeta på avdelningen Miljö, Hälsa & Säkerhet i ett företag där arbetsmiljöfrågorna är högt prioriterade. Din viktigaste uppgift är att arbeta förebyggande så att exponeringar och skador undviks.


Dina arbetsuppgifter i huvudsak
Dina arbetsuppgifter är:
• Deltaga i kemiska riskbedömningar samt i projektgrupper
• Genomföra utredningar och förbättringar av den kemiska arbetsmiljön
• Genomföra kemiska arbetsmiljömätningar
• Klassificering, märkning och riskbedömning av kemikalier
• Samordning av kemikaliefrågor och bevakning av lagstiftning
• Genomföra utbildningar


Vem är du?
Vem är du?
Vi söker dig som har en högskoleutbildning i kemi och är utbildad yrkeshygieniker. Du bör även ha tidigare erfarenhet av kemiska arbetsmiljörisker och kemikaliefrågor inom industrin.
Som person är du en bra problemlösare som trivs med att jobba i en föränderlig miljö. Du är van att ta initiativ och driva projekt samt lösa uppdrag i nära samarbete med våra interna kunder. För oss är det viktigt att du kan se möjligheter och är serviceinriktad och positiv. Vidare ska du ha förmågan att kommunicera och samarbeta med människor på olika nivåer i organisationen. Du är noggrann, metodisk och fokuserad på kvalitet i arbetet.
Då företagets koncernspråk är engelska, vill vi att dina kunskaper i språket är goda, både i tal och skrift.
Eftersom företaget arbetar med produkter för rökavvänjning ser vi helst att du är rökfri.


Om verksamheten
Detta är ett uppdrag hos kund under ett år. Under den tiden är du anställd som konsult via Poolia Lifes Science.
Som konsult på Poolia är du vår allra viktigaste tillgång. För oss är det självklart att vi tar vårt arbetsgivaransvar i alla situationer. Vi är ett auktoriserat bemannings- och rekryteringsföretag med över 30 års erfarenhet att tillsätta kvalificerad kompetens för bolag i tillväxt eller förändring. Denna avgränsning är vår styrka och har gett oss gedigen erfarenhet inom en rad specialistområden, såsom Life Science där vi själva är specialister. Idag är Poolia ett av de mest omtyckta och välkända varumärkena i branschen och samarbetar med Sveriges främsta läkemedels- och livsvetenskapsföretag. Visa mindre

QA Validation Specialist

Our customer in Helsingborg is offering a contractor position for an internal project within the Quality Systems & Compliance department. Products manufactured in Helsingborg are mostly over-the-counter pharmaceuticals and are produced, tested and released according to good manufacturing practices (GMP). The Quality department is responsible for the quality management system that ensures that the requirements set by health authorities worldwide are followe... Visa mer
Our customer in Helsingborg is offering a contractor position for an internal project within the Quality Systems &
Compliance department.
Products manufactured in Helsingborg are mostly over-the-counter pharmaceuticals and are produced, tested and released
according to good manufacturing practices (GMP). The Quality department is responsible for the quality management system
that ensures that the requirements set by health authorities worldwide are followed to assure safe products.


Om tjänsten
The QA Validation Specialist role is part of the Quality System and Compliance team. In this role you will support validation
activities and support site projects.
The position requires knowledge of cGMP and associated industry and regulatory guidance document to reviews and
approve reports and other sources of information to ensure that validations and procedures are in compliance with current
industry, regulatory requirements, and current technology

Dina arbetsuppgifter i huvudsak
Requires knowledge in Computer Software Validation
Possess min 10 years of experience in validation within an API, pharmaceutical, or biotech industry.
Knowledge of validation and qualification principles, and Quality Systems principles (Change Control, Non-Conformance,
CAPA and Risk management).


Vem är du?
Education Level: (Pharmacist, Engineer, Biologist, Chemist, etc.)
Advanced level in Excel (mandatory & non-negotiable)

Language requirement: Excellent in English and Swedish (write, read and speak)
Advanced level in Excel (mandatory & non-negotiable)
Analytical, self-motivated, energetic and self-disciplined person
Problem solver
Fast learner
Good communication skills
Attention to detail
Able to work in a high-paced environment

Core competencies required for this role:
Requires knowledge in Computer Software Validation and Process Validation

Om verksamheten
This is a consultant assignment at a Pharmaceutical Company in Southern Sweden. During the period of the assignment you will be employed by Poolia.

Poolia Life Science is an authorized consultant and recruitment company with more than 30 years‘ of experience in matching qualified competence with world leading companies. Our dedicated team consists of highly experienced researchers and managers within the Life Science field, specialized in understanding the needs and expectations of clients´ as well as the competences and skills of the candidates´. Visa mindre

R&D Q&C Specialist GMP

Poolia Life Science is looking for a candidate with experience in Good Manufacturing Practices (GMP) for one of the world's most comprehensive and broadly-based manufacturer of health care products. If you have the talent and desire to touch the world, our customer in Southern Sweden has the career opportunities to help you make it happen! Om tjänsten Ensure compliance at R&D Q&C both in new development projects with internal and external partners and G... Visa mer
Poolia Life Science is looking for a candidate with experience in Good Manufacturing Practices (GMP) for one of the world's most comprehensive and broadly-based manufacturer of health care products.
If you have the talent and desire to touch the world, our customer in Southern Sweden has the career opportunities to help you make it happen!


Om tjänsten
Ensure compliance at R&D Q&C both in new development projects with internal and external partners and GMP and non-GMP activities. Maintaining and improving internal processes.

Dina arbetsuppgifter i huvudsak
• Deliver on Internal audit plan
• Support supply management process
• Drive document management process as such including but not limited to QMR
• Fulfill the role of training process owner
• Provide Q&C support in project throughout product lifecycle.
• Collaborate with local R&D stakeholders such as Product Design, Analytical Development, Franchise, Regulatory, CMC, Clinical Operations and others to ensure flawless completion of the project and related activities.


Vem är du?

Essential knowledge and skills:
• Education Level: Senior scientist (Pharmacist, Engineer, Biologist, Chemist, etc.)
• Ability to build partnerships internally and externally


Essential duties and responsibilities:
• Knowledge of GMP
• Language requirement: Excellent in English and one or more of any of the Nordic (Swedish, Finnish, Norwegian, Danish) languages (write, read and speak)
• Analytical, self-motivated, energetic and self-disciplined person
• Problem solver
• Fast learner
• Good communication skills
• Attention to details
• Able to work in a high-paced environment






Om verksamheten
This is a one-year consultant assignment through Poolia Life Science, starting in August/September 2021, with a great chance of extension. Poolia Life Science is a specialized recruitment and consultant company with extensive experience in connecting top talents with world-leading companies in the Life Science industry. As a consultant at Poolia Life Science, you will be a key part of our great network of experienced scientists, engineers, and managers, with all the benefits of having a stable and a secure employment. Welcome to join a company, where we understand and value your competence and skills! Visa mindre