Team Member Msat

Year    Andhra Pradesh, India

Job Description


Company DescriptionDr 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.QualificationsB Pharm/M Pharm

Dr. Reddy's Laboratories

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Job Detail

  • Job Id
    JD3485925
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Andhra Pradesh, India
  • Education
    Not mentioned
  • Experience
    Year