Specialist QA

PRPDG

Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.

Summary

Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team.


Requirement

  • Bachelor in Sciences or Engineering, experience in Biotech or Pharmaceutical Industry with 5 years of project experience
  • Experience working with Quality Systems (Work Orders, Job Plans, Equipment Qualification, Cleaning and Process Validation, Deviations, CAPAs, Change Controls, revising controlled documents)

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