The QA contractor acts as a quality expert and applies our Quality Systems to create, review and approve GMP documentation. The contractor works in close collaboration with other departments. First assignment 6 months, Leiden (high chance of extension).
- Activities include, but are not limited to:
- Paper and electronic batch record review
- Raw material release
- Document revisions review and approval
- Review and approve analytical method transfer protocols and reports
- Review and approve change controls, validation protocols and reports, validation assessments, and applicable lifecycle documentation depending on experience.
- Track and monitor the progress of changes to anticipate, flag, and prevent any delays in change implementation.
- Depending on experience supporting master material changes
- BSc/HBO (or equivalent) in bioscience, chemistry, pharmacy or equivalent;
- +1 year of QA experience in pharmaceutical or related industry;
- Up-to-date knowledge of current GMP regulations;
- Experience in Change control and all documenting related activities;
- Experience with documentation systems like Trackwise, True Vault is preferable;
- Good communicative and advisory skills in both Dutch and English, both (verbal and written);
- Able to work independently as well as in a team.
If you are interested in the above description, please apply today. The job interview and offer can take place within the next 2 weeks. For more information, you can contact Merel van Os at +31 (0)20 20 44 502 or via email at firstname.lastname@example.org.