RED is currently hiring a SAP Validation (CSV/PQM, GxP, 21 CFR, SoX) Consultant on behalf of a Global Key Partner to participate on a SAP Roll out Programme. This opportunity is ideal for those looking for a long term contract and to increase their own personal network and brand with a Global brand and organisation.
Please find details below:
Role: SAP Validation Consultant
Location: Basel, Switzerland
Start: 3rd September 2018
Duration/End: 12 Months +
Capacity: Full time, 5 days per week
- Establish Validation Strategy & Approach for SAP global roll out. 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
Education / Experience:
- Able to manage direct relations with stakeholders and project team members. Should have worked in large programs.
- GxP, 21 CFR Part 11, and SOX knowledge
- SDLC and GAMP knowledge
If you are interested or would like to know more details, please email your CV to firstname.lastname@example.org for immediate consideration. Applicants must hold a valid EU Passport or Work Permit for Switzerland.