MS&T

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.