Senior Validation Project Manager

4 weeks ago

Foster City CA, United States Katalyst Healthcares & Life Sciences Full time

Responsibilities: 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 a 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. Requirements: 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.

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