Scientific OfficerAn exciting opportunity has opened up in an innovative medical device company based in Cambridge UK. The Scientific officer will support the assay development...
Quality Compliance Officer
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.
- 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).
- 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
- 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