Lediga jobb QRIOS Minds AB i Helsingborg

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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

Technical Project Manager

Are you an experienced engineer that is looking for a new challenge? Do you have experience working in project management in industrial companies? If yes you might be the one we are looking for! This is a consultant assignment with an initial duration of 13 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! About the position You will be respon... Visa mer
Are you an experienced engineer that is looking for a new challenge? Do you have experience working in project management in industrial companies?
If yes you might be the one we are looking for!

This is a consultant assignment with an initial duration of 13 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!

About the position
You will be responsible for ensuring the technical scope and go live or retirement and decommissioning of Lab Applications. As Technical Project Manager you lead the technical scope and have functional responsibility of user requirements management, design, development, and ensuring compliance and validation certification approvals are met with the right quality and in a timely manner. You have experience in the field and have previously been driving large, innovative and challenging projects with high demands.

Responsibilities
• Retrieve Project Activities from stakeholders (Technology Teams, Business and IT)
• Delivering the project scope through cross functional development and tracking of the cross functional project timelines
• Meet Technology schedules in reference to users’ project timelines
• Regular reporting.
• Support technology development in users’ project reviews and audits.
• Interact closely with different teams, business development, quality compliance and technology.
• Facilitate communication and clarification of technical requirements between users and Technology Teams internal and external (Vendors) stakeholders

Your profile
• A university degree, preferably in Engineering or Computer Science
• PMP certification or MBA a plus
• 5+ years in project management in industrial companies
• Must have worked in a multicultural environment
• Has worked on several projects and/ or bids, ideally in similar business area
• Exceptional stakeholder management, collaboration, and communication skills

About the organisation
This is a consultant assignment at our customer for 13 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

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

Solution Analyst

Ansök    Sep 29    QRIOS Minds AB    Dataingenjör
Are you an experienced engineer that is looking for a new challenge? Do you have experience working as a Business Analyst in IT industry? If yes you might be the one we are looking for! This is a consultant assignment with an initial duration of 13 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! About the position As member of Technology Tea... Visa mer
Are you an experienced engineer that is looking for a new challenge? Do you have experience working as a Business Analyst in IT industry?
If yes you might be the one we are looking for!

This is a consultant assignment with an initial duration of 13 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!

About the position
As member of Technology Team, the Solution Analyst will oversee the creation, testing, and delivery of Lab System Configurations developed by inhouse or vendors Applications Programming Team, by utilizing key skills such as Java Based Programming, web development, database knowledge and lab informatics product knowledge. Interface with users to understand user business processes and gather their functional requirements needed to configure and customize their Laboratory Information Management Systems (LIMS). Document system processes and procedures for users’ requirements and functionality needs. Working either independently or with other team members, to analyze and resolve technical project issues, surrounding functional and design requirements.
The candidate will work with offshore and onsite team members and end-users to ensure Lab informatics applications meets internal processes Quality Standards and industry best practices.


Responsibilities
• Gather, develop, and document functional business requirements for users’ projects. Transform the users’ requirements into functional requirements leveraging available architecture and functionality.
• Interfacing with Configuration Designer and, if necessary, Applications Programmer to ensure the functional requirements and solutions are properly transferred for configuration / development. Review project construction efforts / development.
• Interface with Project Management to ensure strong communication regarding timelines, deliveries, project issues and changes are addressed.
• Aid and guide users in adding master data to the configuration prior to or during the implementation.

Your profile
• Must have at least a Bachelor’s degree in engineering or Masters in Computer, 3-5 years of experience as a Business Analyst in IT industry.
• Working knowledge of the laboratory environment and the various types of instrumentation and instrument software being utilized.
• 1-3 years of technical experience with creating Java-driven Web Applications.
• Must be adept in at least: Java (J2EE), JavaScript, JSP, HTML, DHTML/Web Page Development including client-side scripting and for relational databases (either Oracle and/or Server)
• Other desirable technical skills include Web Service, Ajax, Groovy and J-Query.
• System Analysis, in addition to domain knowledge of laboratory practices.
• A structured approach to working & problem solving
• Good analytical skills and the ability to apply logical thinking to resolve faults and issues with appropriate corrections and measures


About the organisation
This is a consultant assignment at our customer for 13 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

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

Administrative Assistant - Life Science

About the position For our customer in Helsingborg, we are searching for an administrative assistant within Life Science. The right candidate will: • Create / Update Business SOPs • Create / Update Computerized System Validation Documents • Execute tests Your profile • Computer and system knowledge • Laboratory experience • User and author of Stand Operating Procedures for Lab operations • Language requirement: Swedish and/or English languages (write... Visa mer
About the position
For our customer in Helsingborg, we are searching for an administrative assistant within Life Science.

The right candidate will:

• Create / Update Business SOPs
• Create / Update Computerized System Validation Documents
• Execute tests

Your profile
• Computer and system knowledge
• Laboratory experience
• User and author of Stand Operating Procedures for Lab operations
• Language requirement: Swedish and/or English languages (write, read, and speak)
• Computer & System knowledge (order systems, ERP systems).
• 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.
• Experience in writing technical documentation mostly important stand operating procedures


About the organisation
This is a consultant assignment at our customer in Helsingborg for 3 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

Senior Analytical Chemist

Ansök    Maj 23    Qrios Minds AB    Analytisk kemist
Are you an experienced scientist that is looking 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 4 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 At Quality Control Labs (QC Labs), quality cont... Visa mer
Are you an experienced scientist that is looking 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 4 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
At Quality Control Labs (QC Labs), quality control is carried out on raw materials, finished goods and packaging materials for smoking cessation products manufactured for a global market. We are now looking for an analytical chemist who wants to be part of our team at QC Labs and can support the business based on the needs that arise on a daily basis.



Responsibilities
Your main tasks will be to support departments with chemical expertise linked to analytical work. Drive and be responsible for investigations, change controls and troubleshooting, as well as supporting the operational groups with specialist expertise.
In the laboratory, spectroscopic and chromatographic analysis techniques are mainly used. The primary data is documented electronically in LIMS (Laboratory Information Management System). Work is carried out in accordance with GMP. You work both individually and in teams.

Your profile
Special requirements:
• Academic degree with specialization in Analytical/Organic Chemistry
• Experience and deep knowledge in chromatography such as HPLC/UPLC, GC, with advantage within Empower software.
• Experience with the above analytical methods and analytical work
• Experience working in GMP environment
• Language requirement: Swedish and English languages (write, read, and speak)
• Good knowledge in Microsoft Office (Excel, Word, PowerPoint)
• As a person, you are meticulous, you are an independent problem solver with a delivery focus, responsibility and have high collaborative skills.
• 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
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

MBR Designer

Har du erfarenhet av PAS-X, Movex och styrsystem? Då har vi jobbet för dig hos en kund inom medtech i Helsingborg. Du kommer att designa och utveckla befintliga MBR’er samt vara support till användare på företagets anläggningar. Lagspelare med ett stort egenansvar. Engagerad person som aktivt vill medverka till förbättring av processer och rutiner. Arbetet kräver att ha förmågan att arbeta noggrant med arbetsuppgifterna, men samtidigt ha många bollar i lu... Visa mer
Har du erfarenhet av PAS-X, Movex och styrsystem? Då har vi jobbet för dig hos en kund inom medtech i Helsingborg. Du kommer att designa och utveckla befintliga MBR’er samt vara support till användare på företagets anläggningar.
Lagspelare med ett stort egenansvar. Engagerad person som aktivt vill medverka till förbättring av processer och rutiner. Arbetet kräver att ha förmågan att arbeta noggrant med arbetsuppgifterna, men samtidigt ha många bollar i luften.



Dina arbetsuppgifter i huvudsak
• Vara ansvarig för support av befintligt Pax-X system
• Skapa och uppdatera MBR’er
• Underhålla PQ testdokumentation av MBR samt medverka i och ständigt förbättra förändringsprocessen för MBR.
• Utbilda användare i verksamheten i PAS-X superusers.


Vem är du?
Vi ser helst att du har som lägst avslutad gymnasieutbildning samt nedanstående:

• Goda kunskaper i svenska språket, verbalt och skriftligt (krav).
• Grundläggande kunskaper i engelska språket, verbalt och skriftligt (krav).
• Grundläggande datorförståelse, t.ex. Microsoft Office (krav)
• Erfarenhet att supportera & interagera med användare
• Djup erfarenhet av PAS-X (krav).
• Djup erfarenhet av Movex (krav).
• Styrsystem och teknisk kunskap (meriterande)
• Kunskap om GMP


Om verksamheten
Detta är ett konsultuppdrag hos kund i Helsingborg i tre månader till att börja med. Under tiden kommer du vara anställd av QRIOS. Hör av dig för mer information till Alma Foric.

QRIOS kan erbjuda flera möjligheter till dig som är ingenjör eller har en teknisk bakgrund. Våra uppdragsgivare finns inom miljö-, energi-, skogs-, fordons-, läkemedels-, livsmedels-, process- och produktionsindustrin. Oavsett om du vill arbeta på ett stort eller litet företag, inom privat eller offentlig sektor, så har vi en tjänst för dig. Vi förenar människor och teknik!

Att vara konsult hos oss ger dig många möjligheter att prova på olika branscher, företag och roller. Läs gärna mer om hur det är att vara konsult hos oss: https://www.qrios.se/om-oss. Det passar dig som vill få mycket erfarenhet under en kortare period. Om du letar efter en värld fylld av spännande möjligheter och nya kontakter kommer du gilla att vara konsult hos oss. 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

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

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