As a QA Officer you are responsible for ensuring quality within our laboratory and operational processes. You will work according to GxP ISO and internal quality standards and play a key role in documentation control audits training and compliance.
Your responsibilities include:
- Manage and assess deviations changes complaints OOS and CAPA in accordance with GMP guidelines.
- Maintain and monitor the change control and deviation systems.
- Perform routine quality assurance tasks according to SOPs and quality standards.
- Contribute to the assurance of the quality system based on regulatory requirements (and implementation of regulatory changes).
- Participate in QA system initiatives and improvement projects.
- Train personnel on GMP and quality procedures.
- Conduct (internal) audits and support external inspections (e.g. by regulatory authorities).
- Execute report and follow up on self-inspections.
- Create and revise QA procedures and work instructions.
- Maintain the GMP documentation system and archive including electronic systems.
- Support the creation review or updating of QA agreements.
- Manage documentation and compliance related to opiates and precursors.
- Oversee the implementation of new equipment from a QA perspective.
- Ensure compliance in equipment metrology including documentation.
- Review pest control reports and other facility-related quality documents.
Qualifications :
- Bachelors degree or above in (bio) Chemistry Biotechnology (bio) Pharmacy (molecular) Biology or related field -OR- a MBO degree with at least 3 years of experience.
- Minimum of 1 year of experience in the (bio)pharmaceutical industry.
- Minimum of 1 year of experience in a quality oriented environment (GMP / GLP / ISO).
- Organized structured and accurate.
- High quality awareness.
- Proactive and customer orientated team-player.
- Fluency in Dutch or English; knowledge of both is preferred.
- Knowledge of GMP quality system and regulatory requirements (Eudralex ICH).
- Knowledge of biological process development and manufacturing is preferred.
- Located in the Netherlands within reasonable distance of our site in Leiden.
Additional Information :
PROXY and Eurofins: A world of possibilities
This position is based at Eurofins PROXY on the Bio Science Park in Leiden. We have a close-knit team where collegiality and collaboration come first. We offer a responsible and challenging position within the team with room for your own ideas and input. Eurofins PROXY also offers:
- A competitivesalary;
- Flexible working hours;
- 25 days of vacation with the option to purchase 7 additional days (based on a fulltime contract);
- Travel allowance of 23 cents net per kilometer. Are you traveling by public transport Then your travel expenses will be fully reimbursed via NS Business Card;
- Participation in a pension scheme with 50% contribution by Eurofins;
- Each month you accumulate a choice budget balance of 8.5% of your gross salary. This includes among other things holiday pay and a year-end bonus. You can choose to have this amount paid out or you can use it to buy extra days off for example. You choose what suits you best;
- Discount on additional health insurance;
- Tax benefit via FiscFree when purchasing various products and services via your gross salary such as a bicycle sports contribution fitness mobile telephony computers & tablets or a weekend away;
- Professional training and opportunities for training and development;
- Training options via the online learning platform Good Habitz.
Working at Eurofins PROXY offers you the flexibility and personal touch of working in a medium sized and dynamic company whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for our employees:
- Diverse developmental opportunities within the organization;
- A large client portfolio ensures a lot of diversity in your work.
More about Eurofins Scientific
Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food environment pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics discovery pharmacology forensics CDMO advanced material sciences and for supporting clinical addition Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.
Eurofins employs approximately 63000 people worldwide spread across 950 state-of-the-art laboratories and is active in 60 countries with a pro-forma turnover of 6951 million in 2024. Eurofins has strong growth ambitions (CAGR 24%) with in addition to very strong autonomous growth through its own start-ups a large number of acquisitions every year.
Would you like to know more
For questions regarding the position please follow the link below Im interested in order to contact the hiring manager.
Acquisition for this vacancy is not appreciated.
Remote Work :
No
Employment Type :
Full-time
As a QA Officer you are responsible for ensuring quality within our laboratory and operational processes. You will work according to GxP ISO and internal quality standards and play a key role in documentation control audits training and compliance.Your responsibilities include:Manage and assess devi...
As a QA Officer you are responsible for ensuring quality within our laboratory and operational processes. You will work according to GxP ISO and internal quality standards and play a key role in documentation control audits training and compliance.
Your responsibilities include:
- Manage and assess deviations changes complaints OOS and CAPA in accordance with GMP guidelines.
- Maintain and monitor the change control and deviation systems.
- Perform routine quality assurance tasks according to SOPs and quality standards.
- Contribute to the assurance of the quality system based on regulatory requirements (and implementation of regulatory changes).
- Participate in QA system initiatives and improvement projects.
- Train personnel on GMP and quality procedures.
- Conduct (internal) audits and support external inspections (e.g. by regulatory authorities).
- Execute report and follow up on self-inspections.
- Create and revise QA procedures and work instructions.
- Maintain the GMP documentation system and archive including electronic systems.
- Support the creation review or updating of QA agreements.
- Manage documentation and compliance related to opiates and precursors.
- Oversee the implementation of new equipment from a QA perspective.
- Ensure compliance in equipment metrology including documentation.
- Review pest control reports and other facility-related quality documents.
Qualifications :
- Bachelors degree or above in (bio) Chemistry Biotechnology (bio) Pharmacy (molecular) Biology or related field -OR- a MBO degree with at least 3 years of experience.
- Minimum of 1 year of experience in the (bio)pharmaceutical industry.
- Minimum of 1 year of experience in a quality oriented environment (GMP / GLP / ISO).
- Organized structured and accurate.
- High quality awareness.
- Proactive and customer orientated team-player.
- Fluency in Dutch or English; knowledge of both is preferred.
- Knowledge of GMP quality system and regulatory requirements (Eudralex ICH).
- Knowledge of biological process development and manufacturing is preferred.
- Located in the Netherlands within reasonable distance of our site in Leiden.
Additional Information :
PROXY and Eurofins: A world of possibilities
This position is based at Eurofins PROXY on the Bio Science Park in Leiden. We have a close-knit team where collegiality and collaboration come first. We offer a responsible and challenging position within the team with room for your own ideas and input. Eurofins PROXY also offers:
- A competitivesalary;
- Flexible working hours;
- 25 days of vacation with the option to purchase 7 additional days (based on a fulltime contract);
- Travel allowance of 23 cents net per kilometer. Are you traveling by public transport Then your travel expenses will be fully reimbursed via NS Business Card;
- Participation in a pension scheme with 50% contribution by Eurofins;
- Each month you accumulate a choice budget balance of 8.5% of your gross salary. This includes among other things holiday pay and a year-end bonus. You can choose to have this amount paid out or you can use it to buy extra days off for example. You choose what suits you best;
- Discount on additional health insurance;
- Tax benefit via FiscFree when purchasing various products and services via your gross salary such as a bicycle sports contribution fitness mobile telephony computers & tablets or a weekend away;
- Professional training and opportunities for training and development;
- Training options via the online learning platform Good Habitz.
Working at Eurofins PROXY offers you the flexibility and personal touch of working in a medium sized and dynamic company whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for our employees:
- Diverse developmental opportunities within the organization;
- A large client portfolio ensures a lot of diversity in your work.
More about Eurofins Scientific
Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food environment pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics discovery pharmacology forensics CDMO advanced material sciences and for supporting clinical addition Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.
Eurofins employs approximately 63000 people worldwide spread across 950 state-of-the-art laboratories and is active in 60 countries with a pro-forma turnover of 6951 million in 2024. Eurofins has strong growth ambitions (CAGR 24%) with in addition to very strong autonomous growth through its own start-ups a large number of acquisitions every year.
Would you like to know more
For questions regarding the position please follow the link below Im interested in order to contact the hiring manager.
Acquisition for this vacancy is not appreciated.
Remote Work :
No
Employment Type :
Full-time
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