Job Description

To perform QA review of assigned qualification and validation lifecycle documents, including:

  • Validation Master Plans or local validation plans
  • User Requirement Specifications
  • Risk assessments
  • Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification protocols and reports
  • Process Performance Qualification and process validation protocols and reports
  • Cleaning validation documentation
  • Aseptic Process Simulation / Media Fill documentation
  • Computerized system validation packages
  • QC Chemistry and Microbiology qualification or requalification documents
  • Equipment, utilities, facilities, and engineering qualification documentation
  • Requalification, revalidation, and lifecycle review documents

    • To verify that assigned documents include clear scope, predefined acceptance criteria, traceability to user and GMP requirements, defined responsibilitie...

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