Quality Compliance Officer

Job Ref: J31914
Sector: Science
Sub-sectors: Biotech/Life Sciences, Pharmaceuticals
Job Type: Contract
Date Added: 01 July 2019
  • Cambridge, Cambridgeshire, England, UK milton rd Cambridge Cambridgeshire UK cb4 0ws
  • £28,000 - £35,000 per Annum
    ANNUM
  • Bec Johnston2
  • 01223 235203
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Quality Compliance Officer

Cambridge

12 month fixed term contract

Up to £35k p/a

This is a newly created role, working for an international drug development and licensing organisation, supporting the IT system installations, delivery and validation in relation to quality and compliance regulations.

Role profile:

  • Liaison with associate organisations to supply advice and guidance on the development, implementation, operation and maintenance of computerised systems adhering to GxP and SOP's.

  • Support and assist with external audits to check and ensure consistency with automated equipment and applications vendors.

  • Act as Computer Systems Validation Lead, monitor and work towards completion of key project milestones, always ensuring documentation which evidences delivery of milestones.

  • QA witness to the testing phases of projects, production of technical reports to evidence standards have been met to agreed metrics.

  • Change control requests - managing the requests for change controls and supporting the implementation and validations of changes as required.

  • Delivery compliance and quality training to staff, including ongoing training and training needs analysis.

  • Remaining aware of changing international regulatory requirements relating to automated systems.

  • Work closely with other functions of the business to ensure the product can be compliantly distributed to meet demand (warehouse, quality, planning, customers, and supply chain).

Person profile:

Essential:

  • You will demonstrate a sound knowledge and understanding of the Rules Governing Medicinal Products in the EU, GMP, and Annex 11 (Computerised Systems) of Medicinal Products for Human and Veterinary Use

  • FDA 21 CFR Part 11 - Electronic records and signatures

  • ISO 17799:2000 code of practice for IT

Preferred:

  • PRINCE2 would be a benefit, or proven background in running and contributing to successful conception, delivery and completion of projects relating to computerised/automated systems

  • Good awareness of working within the pharmaceutical industry

  • High attention to detail, clear team-spirit in your approach and ability to work under minimal supervision by planning and prioritising your own workload

  • Effective written and verbal communicator

SRG
31/07/2019 19:46:42
GBP 28000.00 28000.00