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SAP S4 Test manager (Compliance -Life Science)

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Cognizant

2mo ago

  • Job
    Full-time
    Expert Level
  • Derby

AI generated summary

  • You must have expertise in FDA regulations, SAP implementation, compliance in Life Sciences, quality assurance, project management, and experience with audits, CAPA, and validation deliverables.
  • You will manage SAP testing, ensure quality compliance, support audits, oversee training and documentation, qualify applications, and coordinate non-conformance risk assessments.

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 Quality Engineering & Assurance (QE&A) Practice?

The SAP S4 Test Manager will be responsible for managing SAP implementation projects, setting up a robust Quality and Compliance framework, supporting audits, and ensuring the quality and compliance of validation deliverables with company policies and standards.

What qualifications are required for the SAP S4 Test Manager position?

Candidates should be well-versed in FDA regulations, 21 CFR Part 11, GxP requirements, and have experience with SAP implementation projects, computer system validation, and quality assurance activities.

Is experience in the Life Sciences industry important for this position?

Yes, experience as a compliance lead for Life Sciences engagements involving SAP implementation is crucial for this role.

What responsibilities does the SAP S4 Test Manager have regarding user access management?

The SAP S4 Test Manager is responsible for the periodic review of user access management and controlled documents.

Will the Test Manager be involved in audits?

Yes, the Test Manager will support internal and customer audits as part of maintaining compliance.

What tools or systems should the SAP S4 Test Manager be familiar with?

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

What is required to ensure training compliance in this role?

The Test Manager will manage training compliance to ensure that all team members are adequately trained on procedures and standards relevant to the QA process.

How does the SAP S4 Test Manager role contribute to risk management?

The Test Manager identifies non-conformances, risks, and documentation gaps and coordinates with the team to address these issues.

What experience is beneficial when applying for this position?

Experience in project management, customer service, compliance frameworks, and conducting root cause investigations for NCs and process deviations will be beneficial for candidates.

What kind of applications will the Test Manager be qualifying or validating?

The Test Manager will be involved in the qualification and validation of both GxP and non-GxP applications in relation to SAP implementation.

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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.