MS&T

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.