Team member MSAT

2 months ago

Visakhapatnam, India Dr Reddy's Laboratories Limited Full time
Job Description

  • Prepare, review and approval of protocols, reports and product impact assessments related to submission batches and process validation batches.
  • Support for regulatory filings and compliance issues for sterile injectable products.
  • Support for regulatory audits.
  • Monitoring and support for scale up, manufacturing of process validation batches and first commercial batch for site to site transfer injectable product and new products from IPDO (as required).
  • Provide support for troubleshooting, root cause analysis and product impact assessments for non-conformance investigations (OOS & OOT) and process changes/improvements.
  • Initiation, review and approval of change controls, Incidents and risk assessment with respect to Validation / qualification activities.
  • Co-ordination with CFTs (i.e. Production, QA, QC) for exhibit batches, process validation, BMR activity and various documentation. 
  • Serve as the fill-finish process as subject matter expert.
  • Review change controls for process related activities.
  • Review of Product Quality reports.
  • Preparation and review of CPV plans.

Qualifications

B. Pharma. or M.Pharma. or B. Tech (chemical engineer) with 5 to 10 years of experience on technology transfer of sterile drug products.



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