- 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.
- Solid 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.

📌 MS&T - Manufacturing investigator (Ahmedabad)
🏢 Zydus Group
📍 Ahmedabad