Dr. Reddys Pharma Jobs: Apply Now for Team Member Position!
Team Member – MSAT
Andhra Pradesh, India
About the job
Company Description: Dr. Reddy’s Laboratories
Job Description:
- Responsible for product transfer, technology absorption, and process qualification activity at FTO – SEZ Process Unit 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.
- Responsible for performing/reviewing investigations arising from incidents, out of specifications, out of trends, product failures, and 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 and change parts.
- Participation in Process Safety Management activities and ensuring safety measures during execution of confirmatory/submission/process qualification batches.
- Coordination with production, quality assurance, regulatory affairs, quality control, supply chain management, and vendors for collection of data/reports.
- Preparation and review of the following documents but not limited to:
- Confirmatory/Submisson/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.
- Perform investigations related to ongoing process verification (OPV) of the products.
- Review of Product Quality Report (PQR).
Qualifications: B Pharm/M Pharm.
Keywords: Team Member, MSAT, Andhra Pradesh, India, Dr Reddys Laboratories, Product transfer, Technology Absorption, Process qualification, SEO. Dr. Reddys Pharma Jobs: Apply Now for Team Member Position! Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
