1. To ensure the cGMP compliance and preparation or review of documents such as SOPs, protocols etc
2. Basic GMP, Refreshing GMP training to all company employees.
3. Handling of customer queries and complaints.
4. Carrying out internal quality system audits to verify compliance with principles of GMP.
5. Product quality reviews, Validation activity, change control and qualification.
6. Investigation and closing for deviation and OOS results and market complaints.
7. Follow up and implementation CAPA and approving and updating the query in EDMS.
8. Batch card review and archival.
9. Approving Master Batch Card and Batch release.
10. Approval of various documents in absence of Associate Director QA
11. Attending customer and regulatory inspections.
12. Any other responsibilities assigned by Associate Director QA / Vice President- QA/ QC/RA.
Responsible for activities such as, GMP compliance, Change controls, Deviations, Investigations and CAPA
Good understanding of Quality Assurance, Understanding of GMP