Validation EngineerKatalyst Healthcares and Life Sciences • Santa Monica, CA, United States
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Validation Engineer
Katalyst Healthcares and Life Sciences • Santa Monica, CA, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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.
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 :
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Validation Engineer • Santa Monica, CA, United States
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