£650.00 - £750.00 per day
over 1 year ago
A market leading Pharma company based in Surrey has the exciting opportunity for an IT Risk & Compliance Expert on an initial 12 month contract. You will have considerable experience in a global Pharmaceutical environment combined with very strong experience with GAMP and SAP. Any cv's without this experience unfortunately cannot be considered.
* Support the transition of ownership of the AICL SAP system from local management to global IS.
* Actively participate in the workstreams where IS R&C are members and review and approve deliverables from the other workstreams.
* Participate in the development, implementation and maintenance of IS Quality Framework documentation to accommodate this transition.
* Assist in the delivery of training to AICl personnel, coaching and mentoring for IS processes.
* Assist in the delivery of training for adopted AICL processes to IS personnel
* Assist in the management of the registration and compliance monitoring of regulatory and quality controls. Escalate any non-conformance in a timely fashion.
* Support the establishment of the R&C support capability for this system and the other EMEA SAP system in the context of a global SAP support organisation.
* Strong SDLC / Validation / Compliance / IT Quality background with good GAMP / SOX / Data Protection and SAP experience.
* Considerable experience in a global pharmaceutical environment.
* Experience of rolling out quality systems globally or regionally.
* Experience of implementing corporate change programmes.
* Working knowledge of electronic document or system change management systems.
* Experienced at working with outsourced partners.