About this role
Job Description
- Review & approval of Quality system related documents like change controls, deviations, market complaint, OOS, IPOOS, OOT & CAPA.
- To monitor and coordinate IPQA activities in manufacturing and packing area.
- Review and approval of master documents like SOPs, protocol and reports, specifications, standard test procedures, batch manufacturing record, batch packing records OPML etc.
- Review and approval of quality risk management.
- Review and approval of APQR and implementation of recommendations from APQR.
- Review and approval of hold time study documents, validation and qualification documents.
- Approval of various documents in SAP system.
- Performing self-inspection, audit of contract testing laboratory/third party vendor audit/vendor audit and review of related documentation.
- Investigation of quality matrices like deviations, out of specification results, out of trend results, market complaints, batch failures etc.
- Handling the regulatory audits/Inspections and ensuring the responses & compliances.
Work Experience
12-15 years
Education
Graduation in Pharmacy
## Competencies