Should know GxP, Validation and possibly MES GxP Documentation is must Seeking a Project Manager with experience in Pharma/ Biotech/ Life Sciences/ Medical Device/ Healthcare or Manufacturing a must (Okay with either industry) Responsibility: • This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, and 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 GxP regulations and 21 CFR Part 11. • Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system. • 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. • 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. Skills: • 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 (European Medicines Evaluation Agency ) guidelines including 21 CFR Part 11. • Excellent knowledge of computer system validation and GAMP -5 standards.