- 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 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
- 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
- Team management
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· 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 ( ...
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Since 2015, Lithos Energy has been a global leader in high-performance lithium-ion battery systems designed for demanding environments. The company provides proprietary and customizable battery systems that empower clients to bring their products to market faster and at scale. Li ...
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Verification and Validation Lead – Chronic Disease Management
Only for registered members
We are seeking a technically skilled and detail-oriented leader to serve as the Verification and Validation (V&V) Lead for our Chronic Disease Management division.This position reports directly to the Head of R&D Workflow Glaucoma & Comprehensive Care and plays a critical role in ...
Dublin $151,400 - $189,200 (USD) Full time3 weeks ago
- Work in company
Verification and Validation Lead – Chronic Disease Management
Only for registered members
Weareseekingatechnicallyskilledanddetail-orientedleader toserveastheVerificationandValidation(V&V)LeadforourChronicDiseaseManagementdivision.Thisrolewilloverseeethe developmentandexectionofV&Vstrategiesandtestingtoolsforadvancedalgorithms,software,hardwareandsystems inophthalmici ...
Dublin $151,400 - $189,200 (USD)3 weeks ago
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· Company Description · Thanks & Regards · Kumar.T | Resourcing Executive · KRG Technologies, Inc., · 25000 Avenue Stanford, Suite #243, Valencia, CA 91355 · Direct : Ext : 303 | · Job Description · JobTitle : Validation Test Lead with Serialization · Location : Foster C ...
Foster City, CA1 week ago
SAP Validation Lead - California City - RxCloud
Description
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.
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