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SAP Pharma Risk & Compliance Expert (GAMP)

SAP Pharma Risk & Compliance Expert (GAMP)

  • Location

    Surrey, England

  • Sector:

    IT

  • Job type:

    Contract

  • Salary:

    £650.00 - £750.00 per day

  • Contact:

    Kelvin Ball

  • Contact email:

    kelvin.ball@volt.eu.com

  • Job ref:

    74530-ITENG-KSB_1561648958

  • Published:

    5 months ago

  • Duration:

    52 weeks

  • Expiry date:

    2019-07-27

  • Start date:

    ASAP

  • Consultant:

    #

RISK & COMPLIANCE - GAMP - PHARMA - SAP

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.

KEY OBJECTIVES

* 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.

EXPERIENCE NEEDED

* 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.