SAP S4 Test manager (Compliance -Life Science)
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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 engineer 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 :
- SAP implementation projects as a Test Manager
- Setup a robust Quality and Compliance framework for all services provided by Cognizant which seamlessly integrated with the clients Quality Management System, Security framework and Privacy needs.
- Supported internal and customer audits.
- Involved in Root Cause investigations to determine CAPAs for NCs and Process Deviations.
- Periodic review of User access management and Controlled documents.
- Manage training compliance.
- Perform End to end review of all the validation deliverables to ensure quality and compliance with company policy and standards.
- Qualification /Validation of Non GxP/ GxP applications with SAP implementation
- Review and approval of Qualification deliverables, Finding and smart control assessments in Archer.
- Identification of Non-Conformance / Risks and Documentation gaps.
- Coordinate with team to provide support and guidance on documentation approach to be followed.
- Ensure Smooth Onboarding of IT Applications in Archer.
Key Kills and Experience :
- Well versed with FDA, 21 CFR Part 11, GxP requirements, Change/Problem/Incident Management, CAPA/Deviation, and periodic reviews.
- Experience in SAP implementation projects as a Test Manager or Functional Consultant
- Understands SAP Implementation SDLC and STLC
- Worked as compliance lead for leading Life Science engagements with SAP implementation
- Experience in Computer System Validation, Quality Assurance QMS activities.
- Proficient in Operations, Project Management, Customer Service & Business Processes.
- Setup a robust Quality and Compliance framework for all services provided by Cognizant which seamlessly integrated with the clients Quality Management System, Security framework and Privacy needs.
- Supported internal and customer audits.
- Involved in Root Cause investigations to determine CAPAs for NCs and Process Deviations.
- Experience in periodic review of User access management and Controlled documents.
- Manage training compliance.
- Perform End to end review of all the validation deliverables to ensure quality and compliance with company policy and standards.
- Qualification /Validation of Non GxP/ GxP applications with SAP implementation
- Review and approval of Qualification deliverables, Finding and smart control assessments in Archer.
- Identification of Non-Conformance / Risks and Documentation gaps.
- Coordinate with team to provide support and guidance on documentation approach to be followed.
- Ensure Smooth Onboarding of IT Applications in Archer.
The Cognizant community:
We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.
- Cognizant is a global community with more than 300,000 associates around the world.
- We don't just dream of a better way - we make it happen.
- We take care of our people, clients, company, communities and climate by doing what's right.
- We foster an innovative environment where you can build the career path that's right for you.
About us:
Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World's Best Employers 2024) is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com
Our commitment to diversity and inclusion:
Cognizant is an equal opportunity employer that embraces diversity, champions equity and values inclusion. We are dedicated to nurturing a community where everyone feels heard, accepted and welcome. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other protected characteristic as outlined by federal, state or local laws.
Disclaimer:
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.