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.

Work arrangement
No