This position is responsible for leading and performing activities in support of creating and maintaining GCP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GCP regulations and 21 CFR Part 11.
• Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system
• Perform GCP 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
• Review the test scripts for the requirements and test scenario coverage
• Lead overall protocol executions, log and track defects
• Review the executed test reports 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
• Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.
• Maintain overall project and issue tracker and report routinely
• 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
• Maintain day to day activities status tracker and report routinely
• Lead the team of validation engineers located in different time zones
• 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
• Excellent knowledge of computer system validation and GAMP -5 standards