Nice project for a QA officer for batch record review and other QA related tasks at our client Janssen Biologics an important player in the biopharmaceutical industry.
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 products and quality systems. To ensure continuity we are looking for additional resources to 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.
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;
BSc/HBO (or equivalent) in bioscience, chemistry, pharmacy or equivalent;
Up to date knowledge of current GMP regulations;
Good communicative and advisory skills in both Dutch and English both (verbal and written);
Good investigative abilities, critical and highly accurate;
Able to work independently as well as working well within a team;
Preferably some years of work experience in pharmaceutical or related industry (QA, QC, Production Operations or supporting functions);
Able to work with and preferably have knowledge of automated systems.
Contract: temporary project through Oxford Global Resources;
Duration: untill end of year 2020;
Salary: €2600,- till €3300,- gross monthly based on level of experience;
Hours full-time preferred 32h discussable;
Holidays: 25 (+12);