Responsibilities and Requirements :
- Support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S / HANA Perform GxP and CFR part 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 GxP requirements and EE 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.
Education & Experience :
- Excellent communication (oral and written) and attention to detail.
- years in Computer System Validation in Life Science domain with minimum + 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 GxP regulations, FDA and EMEA guidelines including CFR Part .
- Excellent knowledge of computer system validation and GAMP - standards.
Validation Expert for S4/HANA
Support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/ HANA Perform GxP and CFR part assessments and develop validation plan. Computer System Validation in Life Science domain with minimum + years of experience in managing large global SAP validation pr...
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