Senior Validation Project Manager at Katalyst Healthcares & Life Sciences
San Mateo, CA 94404
About the Job
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.
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.
