About the role

Sun Pharma's Global Quality & Compliance team seeks an Officer/Sr. Officer QA in Ahmednagar to ensure API manufacturing compliance and batch release. The role involves reviewing BMRs, managing QMS tools like SAP HANA and Trackwise, and coordinating validations and audits. This is an on-site position requiring a chemistry background.

What you’ll do

Review Batch Manufacturing Records (BMR) and Equipment Cleaning Records (ECR) for compliance prior to batch release.
Release or reject materials/batches in SAP HANA after verifying closure of deviations, change controls, and OOS/OOT events in Trackwise.
Coordinate with change control teams to evaluate impacts, derive action items, and review/close actions in Trackwise.
Monitor and track deviations, investigations, CAPAs, market complaints, and change controls within the Quality Management System (QMS).
Participate in cross-functional investigations to identify root causes and close CAPA actions/QMS documents.
Review protocols and reports for equipment qualification, process performance qualification, cleaning validation, and continued process verification.
Conduct GMP walk rounds in manufacturing plants, QC labs, stores, and engineering as scheduled.
Prepare and review Annual Product Quality Reviews (APOR/POR), monthly reports, and certificates of analysis.

What you’ll bring

M.Sc. in Organic or Analytical Chemistry
4-7 years experience in API manufacturing Quality dept

Skills

SAP HANATrackwiseGMPCAPAQMSValidationAPI ManufacturingBatch Release

Benefits

Robust benefits and opportunities for personal and professional growth

Education

M.Sc. (Organic Chemistry / Analytical Chemistry)