The QA acts as a quality expert and applies our Quality Systems to create, review and approve GMP documentation. You will work in close collaboration with other departments (Operations, QC, Planning, R&D etc.)
The 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 progress of changes to anticipate, flag and prevent any delays in change implementation.
- Depending on experience supporting master material changes.