Zydus Lifesciences—MS&T

Job description

Description: Position 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.