RxCloud
SAP Validation Lead
RxCloud, California City, California, us, 93504
About the job 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.
Leads the effort to manage, and/or maintains validation of SAP S/4 HANA systemPerform GxP and 21 CFR part 11 assessments and develop validation planDevelop functional risk strategy and perform functional risk assessmentReview user business process documents and user requirements specificationReview functional, technical and configuration design documentsPrepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocolsReview the test scripts for the requirements and test scenario coverageLead overall protocol executions, log and track defectsReview the executed test reports for the proper documentation of test results and evidenceReview the defects for proper documentation per the checklistPrepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and testedPrepare and approve qualification summary reportParticipates in Corrective and Preventive Action (CAPA), Maintains quality metrics.Maintain overall project and issue tracker and report routinelySupport release management activities by reviewing and ensuring the pre-requisites are completed prior to the releaseReview Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materialsMaintain day to day activities status tracker and report routinelyLead the team of validation engineers located in different time zonesSkills:
Excellent communication (oral and written) and attention to detail8+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projectsAbility 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 11Excellent knowledge of computer system validation and GAMP -5 standardsTeam management
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.
Leads the effort to manage, and/or maintains validation of SAP S/4 HANA systemPerform GxP and 21 CFR part 11 assessments and develop validation planDevelop functional risk strategy and perform functional risk assessmentReview user business process documents and user requirements specificationReview functional, technical and configuration design documentsPrepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocolsReview the test scripts for the requirements and test scenario coverageLead overall protocol executions, log and track defectsReview the executed test reports for the proper documentation of test results and evidenceReview the defects for proper documentation per the checklistPrepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and testedPrepare and approve qualification summary reportParticipates in Corrective and Preventive Action (CAPA), Maintains quality metrics.Maintain overall project and issue tracker and report routinelySupport release management activities by reviewing and ensuring the pre-requisites are completed prior to the releaseReview Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materialsMaintain day to day activities status tracker and report routinelyLead the team of validation engineers located in different time zonesSkills:
Excellent communication (oral and written) and attention to detail8+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projectsAbility 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 11Excellent knowledge of computer system validation and GAMP -5 standardsTeam management