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SAP S4 Test manager (Compliance -Life Science)

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Cognizant

22d ago

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

AI generated summary

  • You should have expertise in FDA, GxP, SAP implementation as a Test Manager, experience in compliance audits, validation deliverables, and a strong understanding of Quality Management Systems.
  • You will manage SAP implementation testing, establish compliance frameworks, support audits, oversee training and documentation, and ensure quality in validation deliverables.

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 an SAP S4 Test Manager at Cognizant?

The SAP S4 Test Manager will be part of the Quality Engineering & Assurance (QE&A) Practice, focusing on setting up a robust Quality and Compliance framework integrated with client systems and supporting SAP implementation projects.

What are the key responsibilities of this position?

Key responsibilities include managing SAP implementation projects, setting up compliance frameworks, supporting audits, conducting root cause investigations, managing training compliance, and performing reviews of validation deliverables.

What specific experience is required for this role?

Candidates should have experience in SAP implementation projects, knowledge of FDA regulations and GxP requirements, and a background in Computer System Validation and Quality Assurance activities.

Is previous experience in the life sciences sector necessary?

Yes, experience as a compliance lead for life science engagements involving SAP implementation is required.

What certifications or knowledge are essential for this position?

Candidates should be well-versed with 21 CFR Part 11 and related GxP requirements, as well as have an understanding of SAP Implementation SDLC and STLC.

Will the Test Manager be involved in audits?

Yes, the Test Manager will support internal and customer audits as part of their responsibilities.

What software tools and frameworks should candidates be familiar with?

Candidates should be familiar with Archer for managing qualification deliverables and smart control assessments.

How does the Test Manager ensure compliance with company policies?

The Test Manager performs end-to-end reviews of all validation deliverables to ensure quality and compliance with company policies and standards.

What kind of training compliance responsibilities will this role have?

The Test Manager will manage training compliance to ensure that all personnel are adequately trained in relevant processes and systems.

How important is it to identify risks and documentation gaps in this role?

Identifying Non-Conformance, Risks, and documentation gaps is a critical part of the role, ensuring that all systems and processes adhere to compliance standards.

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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.