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 Valuable 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 current material specifications and methods of analysis for APIs, excipients, and packaging materials; prepare related specifications and methods of analysis.
Prepare indents as per material and product requirements.
Review specifications for raw materials, packing materials, in-process samples, finished products, and stability protocols as required.

📌 Manager Quality Control Ahmedabad
🏢 Amneal Pharmaceuticals
📍 Ahmedabad