IT/QM Compliance role

Work location: Switzerland - Basel

Duration of contract: 8 -10 Months

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