Validation Specialist
4 weeks ago
Job Summary
Katalyst Healthcares & Life Sciences is seeking a skilled Validation Engineer to support the creation and maintenance of GxP quality and perform GxP and 21 CFR part 11 assessments and develop a validation plan.
Key Responsibilities
- 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.
- Ability 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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