Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company located in Hyderabad, Telangana, India. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited.
Post : MSAT - Team Member NASAL
Job Description
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
9. Perform Investigations related to ongoing process verification (OPV) of the products.
10. Review of Product quality report (PQR) report.
Additional Information
Qualification : M.Pharmacy / B.Pharmacy
Location : Pydibimavaram
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Formulation R&D
End Date : 25th January 2025
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