MS&T

• Position Executive / Senior Executive – Manufacturing Science & Technology (MS&T) Department Manufacturing Science & Technology (MS&T) Qualification B.Pharm / M.Pharm /
• Biotechnology/Chemical Engineering 3 to 8 years of experience in sterile injectable manufacturing Key Responsibilities 1.

Responsibilities

• 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.
• 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.
• 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.
• 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.