- To ensure the compliance & implementation of GMP/GLP & SOP.
- To review and verify over all activities of QA / research Labs / NSF / QC Lab / Eng./ Stores etc.
- To prepare & review all site quality-related documents like SOPs, Site Master File, Validation Master Plan,
- Process Validation protocols, Equipment Qualification Documents, cleaning validation protocols, Analytical method protocols, and other validation documents & reports.
- Review of incidents, Deviations, out of specification & change controls.
- Accountable for ensuring the handling of Rejected Material.
- Review of temperature mapping & calibration
- Responsible for ensuring compliance with various GMP monitoring tools like internal quality audits, self-inspection, and vendor audits.