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.