2-3

Review and approval of analytical documents, raw data, audit trails, calibration/PM records, analyst qualification documents, and reference/working standard qualification records in compliance with GMP and data integrity requirements.

Exposure of analysis for Finished Products. Stability Samples & Raw Materials. Having Knowledge of Analytical Method Validation. Verification & Method Transfer. Having skill for data interpretation, troubleshooting.

Supervises vial manufacturing activities, including dispensing, washing, sterilization, and filling. Manages online documentation for logbooks, BMRs, and BPRs. Executes change controls via TrackWise and updates SOPs, URS, and Quality Risk Assessments to ensure regulatory compliance.

Sun Pharma is Indias No. 1 pharmaceutical company and a leading global player in specialty medicines.

This role focuses on managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. You will partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.

Support system implementation, upgrades, and change management. Work with clients and crosse Functional teams to ensure regulatory compliance 

Ensure the report is prepared as per the respective regulatory and sponsor requirements. Handle sponsors or regulatory queries on lab reports.

HPLC, GC, RM, PM, IP/FP, LIMS, Stability, Sampling, Wet Analysis, MT, MV.

Candidate should have knowledge of IPQA, Validation, QMS. Responsible to adherence cGMP guidelines