Job Description

Description

  • Review & approval of Process, Packaging validation, Submission and Engineering batch protocol/ report
  • Master Batch record review (Validation, scale up, Exhibit, Engineering, Commercial)
  • Executed Batch records review (Validation, scale up, Exhibit, Engineering, Commercial)
  • Handling of New Product introduction activity
  • Review & approval of protocols & reports as a part of Investigation
  • Hold time study protocol/ report review & approval
  • Review & approval of cleaning validation protocols, verification protocols and reports.
  • SOP preparation and review
  • Performing & Handling of self-inspection activity.
  • Review & approval of risk assessments & impact assessment
  • Root cause identification and Incident investigation activities
  • Commercial dispatch activity as per site monthly schedule

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