Website Zydus group ltd
Post Name: Executive / Senior Executive – Manufacturing Science & Technology (MS&T)
Department: Manufacturing Science & Technology (MS&T)
Qualification: B.Pharm / M.Pharm / M.Sc. / B.Tech Biotechnology/Chemical Engineering
3 to 8 years of experience in sterile injectable manufacturing
Key Responsibilities:
1. Technology Transfer
Coordinate new product and process technology transfer from R&D/site transfer teams to commercial manufacturing.
Review and prepare technology transfer documents, manufacturing instructions, and risk assessments.
Support exhibit batches, engineering batches, and process qualification batches.
2. Process Validation
Prepare and review Process Validation Protocols and Reports.
Execute Process Performance Qualification (PPQ) activities.
Perform continued process verification and trend analysis.
Evaluate critical process parameters and critical quality attributes.
3. Manufacturing Support
Provide scientific and technical support to production departments such as:Compounding
Aseptic Filling
Vial Washing
Sterilization/Autoclave
Lyophilization
Investigate process deviations and recommend corrective actions.
Support resolution of manufacturing issues and improve process robustness.
4. Risk Assessment & Investigation
Participate in root cause analysis for deviations, OOS, OOT, complaints, and failures.
Conduct risk assessments using tools such as FMEA and Fishbone Analysis.
Prepare CAPA effectiveness evaluations.
5. Documentation & Compliance
Prepare and review:Process validation documents
Technical protocols and reports
Change controls
Risk assessments
Product Quality Reviews (PQR/APR)
Ensure compliance with cGMP, USFDA, MHRA, EU GMP, WHO, and other regulatory requirements.
6. Continuous Improvement
Identify process improvement opportunities to enhance productivity and reduce rejection rates.
Analyze process capability and manufacturing trends.
Participate in Lean Manufacturing and Operational Excellence initiatives.
