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SAP S4 Test manager (Compliance -Life Science)

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Cognizant

2mo ago

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

AI generated summary

  • You should have expertise in FDA regulations, SAP testing experience, compliance leadership in life sciences, QMS activities, and proficiency in validation, training compliance, and audit support.
  • You will manage SAP implementation testing, enforce compliance frameworks, support audits, review user access, validate applications, and ensure documentation quality and risk identification.

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 main responsibility of the SAP S4 Test Manager in this role?

The main responsibility is to manage SAP implementation projects as a Test Manager while setting up a robust Quality and Compliance framework that integrates with the client’s Quality Management System, Security framework, and Privacy needs.

Is experience in life sciences essential for this role?

Yes, experience in life sciences is essential, especially as the compliance lead for engagements involving SAP implementation.

What regulatory requirements should candidates be familiar with?

Candidates 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 types of applications will the Test Manager be working with?

The Test Manager will be working with Non-GxP and GxP applications associated with SAP implementation.

Are there any specific tools or systems the candidate should be familiar with?

Yes, familiarity with Archer for managing qualification deliverables, finding assessments, and smart control assessments is important.

What is a key aspect of the review process in this role?

A key aspect involves performing end-to-end reviews of all validation deliverables to ensure they comply with company policies and standards.

How does the role support audits and compliance?

The role involves supporting both internal and customer audits and participating in root cause investigations to determine corrective and preventative actions (CAPAs) for non-conformances and process deviations.

Is training compliance part of the responsibilities?

Yes, managing training compliance is one of the responsibilities of the SAP S4 Test Manager.

Will the Test Manager need to coordinate with different teams?

Yes, the Test Manager will need to coordinate with the team to provide support and guidance on documentation approaches and ensure smooth onboarding of IT applications in Archer.

Does the role emphasize a comprehensive quality management framework?

Yes, setting up a robust Quality and Compliance framework that aligns seamlessly with client requirements is a crucial aspect of this role.

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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.