Jobid=4982574870ac (0.0746)
Senior QA Officer Product Release
Location Leiden (NL) – 36-40 hours
This role is based in the Netherlands. Applicants must be eligible to work in the Netherlands.
As a Senior QA Officer Product Release you have a broad and diverse range of tasks. Together with your colleagues within the QA ( Product Release department) you ensure GxP compliance within the organization and are involved in day to day activity like and not limited to the review batch records.
Your tasks
Review of batch records
Review and release of incoming goods (raw materials, packaging component etc.)
Lead and support change controls and small-scale QA projects
Draft and maintain procedures and work instructions translating GMP-guidelines to internal standards and procedures,
Advise cross-functional teams on quality-related topics,
Person in plan
Promote the quality policy and translate GMP guidelines into internal standards
Advocating for ongoing Continuous Improvement within and outside QA
Participate in regulatory inspections (e.g. back office lead, screener)
Compile Product Quality Reviews (PQR)
You have
A completed HBO degree in Life Sciences or equivalent through experience
3-5 years years’ experience in a QA role within the pharmaceutical industry
Proven experience with batch record review
Solid understanding of Quality Systems (deviations, CAPAs, change control, complaint)
Excellent knowledge of GMP guidelines
Experience with Product Quality Reviews (PQR) is a plus
Strong communication skills in English and Dutch (minimum reading and writing)
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