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SAP S4 Test manager (Compliance -Life Science)

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Cognizant

27d ago

  • Job
    Full-time
    Expert Level
  • IT & Cybersecurity
  • Derby

AI generated summary

  • You must have expertise in FDA, 21 CFR Part 11, GxP, SAP testing/implementation, compliance, quality assurance, and experience with audits, documentation, and training management.
  • You will oversee SAP testing, establish compliance frameworks, support audits, review documentation, ensure training compliance, manage non-conformances, and facilitate IT application onboarding.

Requirements

  • 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.

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.

FAQs

What is the role of the SAP S4 Test Manager in the Compliance - Life Science position?

The SAP S4 Test Manager is responsible for overseeing SAP implementation projects, setting up a robust Quality and Compliance framework, supporting audits, managing training compliance, and ensuring the quality and compliance of validation deliverables.

What industries does Cognizant’s Quality Engineering & Assurance practice serve?

Cognizant serves more than 650 clients across various industry verticals, with a particular focus on quality engineering and assurance.

What experience is required for the SAP S4 Test Manager position?

Candidates should have experience in SAP implementation projects as a Test Manager or Functional Consultant, understanding SAP SDLC and STLC, compliance leadership in Life Science engagements, and experience in Computer System Validation and Quality Assurance QMS activities.

What regulatory requirements must the SAP S4 Test Manager be familiar with?

The candidate should be well-versed with FDA regulations, specifically 21 CFR Part 11, as well as GxP requirements, Change/Problem/Incident Management, and CAPA/Deviation processes.

What tools or platforms is the SAP S4 Test Manager expected to work with?

The role involves working with validation deliverables and documentation processes in Archer, including reviewing and approving qualification deliverables.

How does this role contribute to audits?

The SAP S4 Test Manager supports both internal and customer audits, ensuring that compliance standards are met and that any non-conformances or process deviations are addressed.

What are some key responsibilities of the SAP S4 Test Manager?

Key responsibilities include setting up a compliance framework, conducting root cause investigations, managing training compliance, and performing end-to-end reviews of validation deliverables.

What types of applications will the Test Manager be involved with?

The Test Manager will be involved in the qualification and validation of both Non-GxP and GxP applications associated with SAP implementation.

Does the position require management of user access and controlled documents?

Yes, the Test Manager will perform periodic reviews of user access management and controlled documents as part of compliance responsibilities.

What is required for smooth onboarding of IT applications?

The SAP S4 Test Manager is responsible for ensuring the smooth onboarding of IT applications within the Archer system.

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Cognizant

Consulting
Industry
10,001+
Employees

Mission & Purpose

Cognizant is a multinational technology company that provides a wide range of IT services and solutions to organisations worldwide. Their primary focus is on helping businesses transform and thrive in the digital age. Cognizant's mission and purpose are centred around delivering innovative and cutting-edge technology solutions that drive client success. They offer services such as digital strategy, consulting, technology implementation, and IT outsourcing, enabling companies to adapt to evolving market dynamics, enhance operational efficiency, and deliver exceptional customer experiences. Cognizant's ultimate goal is to empower their clients with the tools, insights, and capabilities needed to navigate complex technological landscapes and achieve their business objectives in an increasingly digital world.