QA Officer Support
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Biologics B.V., we are searching for a QA Officer Support.
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.
The department QA Operations Commercial Products generates and manages several quality systems and is responsible for the release of products. The division also provides advice on quality related issues to the various production and production supporting departments and plays an active role in several projects, such as the Manufacturing Execution Systems (MES) project.
The QA-Operations Commercial Products department actively works together with other departments within the Leiden facility and within the Janssen Supply Chain network to assure the quality of our products and quality systems.
Are you looking for a new challenge where you can use your quality skills in an exciting pharmaceutical environment? We are looking for a candidate who can support the QA department in base business tasks.
Main focus areas involve Batch documentation review, review and approve incoming raw material requests and subsequent release. Other review and assessments are performed for but not limited to document changes, change control and validation related documents.
Activities and responsibilities:
- Review of paper and electronic Batch Records on completeness, clarity and GMP compliance;
- Review of raw material related documentation and release of raw materials;
- Provide advice to requesting departments regarding GMP aspects;
- Review and approve QA controlled documentation (SOP’s, Batch Records, work instructions);
- Assessing change requests on consistency, relevance, GMP compliance and clarity;
- Review and Preparation of batch release documentation;
- Support the department in continuous improvement activities.
Who we're looking for
The ideal candidate has a BSc/HBO in bioscience, chemistry, pharmacy or equivalent and some years of work experience in pharmaceutical or related industry (QA, QC, Production Operations or supporting functions). You have up to date knowledge of current GMP regulations and (working) knowledge of automated systems. As a person you have strong communication skills in both Dutch and English, you are critical and highly accurate. Additionally, you are able to work independently as well as within a team.
Are you the QA officer we are looking for?
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: 32-40 hours per week (must be available on site on Wednesdays). Project for at least 8 months, longer-term may be possible in case of strong performance & budget.
Contactperson: Aniek Vugts
Phone: +31 (0)88 22 77 555