1. Manage technology transfer of pharmaceutical products from R&D to manufacturing sites.
2. Execute scale-up, exhibit, pre-validation, process qualification, and placebo batches.Review BMRs, BMIs, process validation documents, specifications, and R&D documentation.
3. Prepare and review protocols, reports, risk assessments, stability studies, and technology transfer documents.
4. Handle QMS activities, including Change Controls, Deviations, CAPA, OOS, OOT, OOE, and investigations.
5. Coordinate with cross-functional teams for material planning, regulatory submissions, and product launches.
6. Support audits, regulatory inspections, and compliance activities.Manage SAP BOM/Recipe creation and process development documentation.
7. Drive process improvement initiatives and ensure cGMP compliance.
8. Prepare SOPs, manufacturing investigations, process flow charts, and yield proposals.