MSAT- Team Member NASAL

1. Responsible for Product transfer, Technology Absorption, Process qualification activity at FTO –SEZ Process Unit 1 Nasal.
2. Responsible for Execution and Monitoring of Confirmatory / Submission / Pre-validation / Process qualification batches for technology transfer of products, Continued process verification, Process simplification, machine change, batch size change and other routine validation  / Qualifications.
3. Responsible to perform/review the investigations arising from incidents, out of specifications, out of trends, product failures, market complaints to identify the root cause and implement appropriate corrective and preventive actions.
4. Process / Product Risk evaluation and recommendation on proposed changes.
5. Review of Tooling drawings, change parts.
6. Participation in Process Safety Management activities and ensuring safety measures during execution of Confirmatory / Submission / Process qualification batches.
7. Co-ordination with Production, Quality Assurance, Regulatory Affair, Quality Control, Supply Chain Management & vendors for collection of data /reports.
8. Preparation, Review of following documents but not limited to,

• Confirmatory/ Submission/ Pre-validation/ Process qualification batches Protocol & Report.
• Master Formula Record, Manufacturing Instruction, Packing Instruction, Process Order Raw Material, Process Order Packing Material, Master Batch Record in Process Automation System (i.e. PAS|X).
• Preparation and review of material reservation in System Application and products (i.e. SAP).
• Equivalency Report /Justification Report, Hold time Study Protocol and Report.
• Stability Protocol, Review of stability batch data.
• License application of the technology transfer products.
• Preparation and review of Standard Operating procedure.
• Compilation and compliance to Technology transfer SOP Checklist.
• SHE Report preparation for site transfer products

1.9        Perform Investigations related to ongoing process verification (OPV) of the products.

1.10      Review of Product quality report (PQR) report.

M Pharmacy/ B Pharmacy