Full Job Description
SAP Validation Lead
Job Requirements:
This position is responsible for leading and performing activities in support of creating and maintaining GxP (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 GxP regulations and 21 CFR Part 11.
37Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system37Perform GxP and 21 CFR part 11 assessments and develop validation plan37Develop functional risk strategy and perform functional risk assessment37Review user business process documents and user requirements specification37Review functional, technical and configuration design documents37Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols37Review the test scripts for the requirements and test scenario coverage37Lead overall protocol executions, log and track defects37Review the executed test reports for the proper documentation of test results and evidence37Review the defects for proper documentation per the checklist37Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested37Prepare and approve qualification summary report37Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.37Maintain overall project and issue tracker and report routinely37Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release37Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials37Maintain day to day activities status tracker and report routinely37Lead the team of validation engineers located in different time zones
Skills:
37Excellent communication (oral and written) and attention to detail378+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projects37Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.37Excellent knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 1137Excellent knowledge of computer system validation and GAMP -5 standards37Team management
