Validation Expert for S4HANA Implementation - Katalyst Healthcares & Life Sciences
Bay area, CA 94953
About the Job
Responsibilities:
- Support of creating and maintaining GDPs (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA Perform GDPs and 21 CFR part 11 assessments and develop 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 GDPs requirements and E2E GDPs 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.
- Excellent communication (oral and written) and attention to detail.
- 8+ years in Computer System Validation in Life Science domain with minimum 3+ years of 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 GDPs regulations, FDA and EMEA guidelines including 21 CFR Part 11.
- Excellent knowledge of computer system validation and GAMP -5 standards.
Source : Katalyst Healthcares & Life Sciences
