Support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA Perform GxP 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 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
Required Skills:
Must have Computer system Validation experience in the Life Sciences Industry
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 GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11 (MUST HAVE)
Excellent knowledge of computer system validation and GAMP -5 standards