IT Quality Manager - Compliance - SAP

Recruiter
Reuben Chase Ltd
Location
London (Greater)
Posted
12 Oct 2018
Closes
10 Nov 2018
Sector
Accountancy
Contract Type
Permanent
Hours
Full Time
Re : IT Quality Manager - Compliance - SAP One of our IT business partners has a requirement for IT Quality Manager- Compliance based in Basel, Switzerland. Please find below the job specification. Mandatory Skills: 8 -12 years’ relevant work experience in IT/QM compliance Must have good working experience in Computerized System Validation Establish Validation Strategy & Approach for SAP global rollout. Author Master Validation plan and Validation plans, regulatory assessments as required Excellent English communication skills, both written and oral Experience in SAP Global Roll outs. Should have worked in large programs. Job description/Skills: Establish Validation Strategy & Approach for SAP global rollout. Author Master Validation plan and Validation plans, regulatory assessments as required Understand and guide the teams on the SOPs on Computerized System Validation, Project Management, Change Management, Document Management and Quality Management and ensure the validation state is attained for the project. Support project managers on the application of the project methodology Driving achievements of the Validation/Quality goals by ensuring that the process and standards defined for the project are followed Escalating project quality issues to Project Sponsors/Program manager Along with the program/project manager, prepare and reply to project-related CSV or audits, assessments or inspections where applicable Supporting PM in risk management activities Along with the project manager, participate and document project handover to operations Change management from quality manager role perspective Create/review and approve high level project deliverables (project management and quality management) Record project-originated GxP deviations where applicable Reviewing and managing test deviations from compliance perspective Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable. Good to have skills: GxP, 21 CFR Part 11, and SOX knowledge SDLC and GAMP knowledge Additional languages would be a plus Support project managers on the application of the project methodology Driving achievements of the Validation/Quality goals by ensuring that the process and standards defined for the project are followed Escalating project quality issues to Project Sponsors/Program manager Along with the program/project manager, prepare and reply to project-related CSV or audits, assessments or inspections where applicable Supporting PM in risk management activities Along with the project manager, participate and document project handover to operations Change management from quality manager role perspective Create/review and approve high level project deliverables (project management and quality management) Record project-originated GxP deviations where applicable Reviewing and managing test deviations from compliance perspective Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable Thanks.

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