Preferred Industry Background: Candidates from reputed pharmaceutical organizations with experience in Topical/Semi-Solid Manufacturing Facilities will be preferred.
Job Overview:
We are seeking a detail-oriented and experienced Manufacturing Investigator to join our MS&T; function at the Ahmedabad Topical Site. The role involves end-to-end handling of quality investigations (OOS/OOT), root cause analysis, deviation investigations, and execution of Part B investigations in compliance with cGMP requirements. The incumbent will work closely with cross-functional teams to identify root causes, implement CAPAs, and support continuous improvement initiatives across topical manufacturing operations.
Key Responsibilities
• Handle quality events including Out of Specification (OOS) and Out of Trend (OOT) cases for the Topical Manufacturing Facility.
• Execute Part B (Manufacturing/Process Investigation) for topical products including creams, ointments, gels, lotions, and other semi-solid dosage forms.
• Review Part A Analytical Investigation Reports to understand failure trends and investigation outcomes.
• Perform comprehensive Root Cause Analysis (RCA) for process deviations and quality events.
• Review and evaluate Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), analytical data, and process-related documentation.
• Assess manufacturing parameters, equipment performance, and process controls during investigations.
• Review Process Validation Reports, Engineering Batch Reports, Technology Transfer Documents, Risk Assessments, and OPV Reports.
• Prepare scientifically justified investigation reports with supporting raw data and evidence.
• Drive effective implementation and monitoring of Corrective and Preventive Actions (CAPA).
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