Role will be part of our Quality Engineering & Assurance (QE&A) Practice. With more than 650 clients across industry verticals and a global footprint, Cognizant QE&A practice is a recognized thought leader in quality engineering and assurance. As enterprises simplify, modernize and secure their legacy environments for the digital era, robust quality engineering and assurance is essential. Quality takes an end-to-end connotation and must straddle both legacy and digital systems. Cognizant QE&A is reimagining QE&A, employing an end-to-end ecosystem approach with intelligent and automated QA processes. In so doing, increasing quality and speed to promote faster business and technology change, as well as a better customer experience.
Key Responsibilities:
1. SAP implementation projects as a Test Manager
2. Setup a robust Quality and Compliance framework for all services provided by Cognizant which seamlessly integrates with the clients' Quality Management System, Security framework, and Privacy needs.
3. Support internal and customer audits.
4. Involve in Root Cause investigations to determine CAPAs for NCs and Process Deviations.
5. Periodic review of User access management and Controlled documents.
6. Manage training compliance.
7. Perform end-to-end review of all the validation deliverables to ensure quality and compliance with company policy and standards.
8. Qualification/Validation of Non GxP/GxP applications with SAP implementation.
9. Review and approval of Qualification deliverables, Findings, and smart control assessments in Archer.
10. Identification of Non-Conformance/Risks and Documentation gaps.
11. Coordinate with team to provide support and guidance on documentation approach to be followed.
12. Ensure smooth onboarding of IT Applications in Archer.
Key Skills and Experience:
1. Well versed with FDA, 21 CFR Part 11, GxP requirements, Change/Problem/Incident Management, CAPA/Deviation, and periodic reviews.
2. Experience in SAP implementation projects as a Test Manager or Functional Consultant.
3. Understands SAP Implementation SDLC and STLC.
4. Worked as compliance lead for leading Life Science engagements with SAP implementation.
5. Experience in Computer System Validation, Quality Assurance QMS activities.
6. Proficient in Operations, Project Management, Customer Service & Business Processes.
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