My client is a renowned Biotech Company in the Netherlands who are urgently in need of a QA Specialist to assist with a 6 month project. 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
- BSc in biotech/pharma industry
- +5 years of experience in GMP within QA role; in the Biopharma Sector
- Dutch and English language skills
- Able to start ASAP in the Randstad area and be a pro-active member of the team
Start Date: ASAP
Duration: 6 months (extension highly likely)
Interested? Get in touch ASAP by sending your CV to email@example.com as interview + offer will happen this week.