- Plan and execute AMV, Analytical Method Transfer (AMT), and method verification activities for various pharmaceutical products.
- Perform routine testing and analysis of raw materials, in-process samples, finished products, and stability batches.
- Operate, calibrate, and troubleshoot high-tech laboratory instruments like HPLC, GC, UV-Vis, and UPLC.
- Ensure strict adherence to GLP, GMP, and internal SOPs. Prepare comprehensive AMV protocols and reports.
- Identify and troubleshoot non-conforming results, handle Out-of-Specification (OOS) investigations, and draft root-cause reports.
- Assist in internal assessments and support external regulatory audits