Dr Reddys laboratories
- Responsible for Product transfer, Technology Absorption, Process qualification activity at FTO –SEZ Process Unit 1.
- 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.
- 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.
- Process / Product Risk evaluation and recommendation on proposed changes.
- Review of Tooling drawings, change parts.
- Participation in Process Safety Management activities and ensuring safety measures during execution of Confirmatory / Submission / Process qualification batches.
- Co-ordination with Production, Quality Assurance, Regulatory Affair, Quality Control, Supply Chain Management & vendors for collection of data /reports.
- 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.
B Pharm/M Pharm
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