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$60 - $65 Per Hour
San Francisco, CA, United States
6 months ago
Job Requirements: 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 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 guidelines including 21 CFR Part 11 • Excellent knowledge of computer system validation and GAMP -5 standards
$60 - $65 Per Hour