Quality Assurance Manager and Project CoordinatorCambs-Herts borderPermanentUp to £48k per annumWorking for a specialist provider of biological and clinical samples to the life-science market, to...
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