Description
Description:

This role involves performing complex routine and non-routine analytical testing on various pharmaceutical materials and products using a wide range of analytical techniques (Simple: HPLC, UPLC, GC, Dissolution, UV-Vis, FT-IR, Karl Fischer etc. and Sophisticated: LCMS, GCMS, XRPD, ICP-MS). Key responsibilities include independently performing method verification, transfer, and validation, conducting stability studies, and operating, maintaining, calibrating, and troubleshooting analytical instrumentation, including sophisticated equipment.The role requires meticulous documentation following GDP and ALCOA principles, preparing reports and Certificates of Analysis, and managing laboratory samples according to SOPs. A solid emphasis is placed on quality and compliance, strictly adhering to cGMP, GLP, and company procedures, identifying and investigating OOS/OOT/atypical results, and implementing CAPAs.The role will also be responsible for laboratory maintenance, safety protocols, waste disposal, equipment calibration, and inventory management. Additionally,



the role involves continuous improvement activities such as training junior analysts, providing feedback on methods, staying updated with regulations, and participating in training programs.

Essential Functions:
- Perform routine and non-routine testing of pharmaceutical samples using techniques such as HPLC, GC, and LC-MS, while supporting method validation and troubleshooting.
- Operate, calibrate, and maintain analytical instruments, ensuring proper functionality and assisting with equipment qualifications.
- Accurately record test data in compliance with GDP and ALCOA principles, and prepare reports, CoAs, and related documentation
- Manage sampling, logging, storage, and disposal of materials, including stability sample activities as per protocols
- Ensure compliance with cGMP, GLP, and SOPs/ promptly reporting any OOS, OOT deviations and laboratory incidents/ supporting investigatio

📌 Senior Officer, Quality Control (Hyderabad)
🏢 Amneal
📍 Hyderabad