MS&T - Manufacturing investigator

• Role: Manufacturing Investigator
• Designation: Executive / Assistant Manager
• Department: MS&T – Manufacturing Investigator
• Location: Ahmedabad (Topical Site)
• Company: Zydus Lifesciences Ltd.
• Experience: 5–10 Years

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).
• Develop and revise SOPs, protocols, investigation templates, and quality documentation as applicable.
• Perform trend analysis of process and quality attributes using statistical tools.
• Collaborate with QA, QC, Production, Engineering, and Supply Chain teams for timely closure of investigations.
• Ensure compliance with cGMP, GDP, Data Integrity, and regulatory requirements.
• Support internal audits, regulatory inspections, and continuous quality improvement initiatives.
• Participate in training programs and contribute to knowledge-sharing activities within the organization.

Key Requirements :

• B.Pharm, M.Pharm, M.Sc., or equivalent qualification.
• 5-10 years of experience in pharmaceutical manufacturing, MS&T, Production, Quality Assurance, or Investigation functions.
• Hands-on experience in Quality Investigations (OOS, OOT, Deviations), RCA, and CAPA management.
• Exposure to Topical/Semi-Solid Manufacturing including creams, ointments, gels, lotions, and similar dosage forms.
• Strong understanding of cGMP, GDP, Data Integrity, and regulatory guidelines (USFDA, MHRA, EU GMP, TGA).
• Experience in batch record review, process investigation, and data evaluation.
• Knowledge of statistical trend analysis and process monitoring.
• Strong analytical, documentation, and technical report-writing skills.
• Excellent communication and cross-functional stakeholder management skills.
• Ability to independently lead investigations and drive timely closure of quality events.