Role & responsibilities
- Pharmacopeial Updation and notification of updated to all India regions.
- Evaluation of Low molecules nitrosamine impurities and NDSRI of all commercial products
- Evaluation of post approval changes and assessment of Nitrosamine, Element impurities and residual solvent
- Review of justification of audit trail related with empower and other than empower software of QC and ARD.
- Preparation/Review of Method Transfer, Method Verification protocol and report in QC.
- Oversee stability samples as per approved stability protocols, including charging, retrieval, and documentation.
- Oversee the movement of stability samples related charging and withdrawal form stability chambers.
- Troubleshooting in LIMS.

Assessment of Vendor notification
- ANDA and Post approval regulatory submission
- Regulatory submission of International, Latam and EU Market
- Assessment of CFT Change control.
- Initiation and assessment of Change control for post approval material/components and finished products
- Review of specification and MOA (Excipients,



finished products and packaging materials etc.)
- Review of QRM, APQR, Hold time, process validation, cleaning validation protocol and reports
- Arrangement of three lots for vendor qualification program and preparation of vendor qualification testing report.
- Review of DDP/DHF and Miscellaneous protocols and reports.
- Review Quality Control (QC) Standard Operating Procedures (SOPs).
- Review instrument logbooks and raw data for raw materials, packing materials, miscellaneous materials, in-process samples, finished products, and water analysis.
- Maintain workplace cleanliness and ensure compliance with Good Laboratory Practices (GLP).
- Prepare study protocols related to laboratory activities. Documentation
- Prepare vendor qualification reports and comparison reports; summarize Amneal test results and vendor test reports.
- Coordinate with the ARD department for recent material specifications and methods of analysi

📌 Manager Quality Control (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad