• Preparation and review of Product Quality review. • General documents and Co-ordination with other departments for cGMP compliances. • Vendor Audit perform, review & maintain Vendor Qualification Documents. • Vendor related activities and material management in SAP & LIMS. • Preparation & Review of Approved Vendor list. • Preparation & Review of Internal Audit Schedule & maintain Internal Audit Document. • Plant round. • Preparation and maintained all master documents and issuance registers records and retrival of documents. • Audit related work. • Review of filled batch process records of intermediate and SRP. • Review of filled batch process records of finished product. • Review of master batch process record of intermediates and SRP. • Review of master batch process record of finished product. • Release finished product/Intermediate. • Regulatory related documents review and submission. • Preparation of process validation & cleaning validation protocol/Report & review. • Preparation of Quality Risk management. • Handling of Change Control, Deviation, OOS/OOT, CAPA & market complaint related activity. • Preparation of Standard Operating Procedure and its training.
