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Validation Engineer
Validation EngineerKatalyst Healthcares and Life Sciences • Santa Monica, CA, United States
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Validation Engineer

Validation Engineer

Katalyst Healthcares and Life Sciences • Santa Monica, CA, United States
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  • [job_card.full_time]
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Responsibilities :

  • Support of creating and maintaining GxP (GMP, GCP, GLP) quality and Perform GxP and 21 CFR part 11 assessments and develop a validation plan.
  • Develop functional risk strategy and perform functional risk assessment.
  • Review user business process documents and user requirements specification.
  • Review functional, technical and configuration design documents.
  • Prepare and / or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols.
  • Draft the OQ & PQ test scripts for the GxP requirements and E2E GxP test scenarios.
  • Support overall protocol executions, log and track defects.
  • Review the executed test protocols for the proper documentation of test results and evidence.
  • Review the defects for proper documentation per the checklist.
  • Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested.
  • Prepare and approve qualification summary report.
  • Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release.
  • Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI), and training materials.

Requirements :

  • Excellent communication (oral and written) and attention to detail.
  • Experience in CSV / Validation in Pharmaceuticals or Medical Device domain with experience in managing large global SAP validation projects.
  • bility to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
  • Excellent knowledge of computer system validation and GAMP -5 standards.
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    Validation Engineer • Santa Monica, CA, United States

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