Job Reference: J5633080
Updated On: 31/03/2020
Status: Now Interviewing
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Role OverviewWe are currently looking for a Computerised Systems QA Lead to join a leading Drug Development company based in the Cambridgeshire area. As the Computerised Systems QA Lead you will be responsible for ensuring that the IT systems, products and services are delivered, installed, validated and maintained throughout their lifecycle to ensure compliance with regulatory requirements.
Key Duties and Responsibilities1. Liaise with independent associated companies to provide expert support and guidance for the development, implementation, maintenance, operation & retirement of suitably qualified / validated automated systems in accordance with current GxP’s and departmental SOPs.
2. Lead and perform external quality audits of prospective automated equipment & applications vendors to determine compliance with recognized Quality Systems & System Development Life-cycle (SDLC) processes.
3. Maintain up to date knowledge of current international regulatory requirements with respect to automated and computerised systems.
4. Provide leadership and support for the governance of international IT Quality Systems and participate in projects concerning systems such as QMS, LMS, DMS.
Role RequirementsExperienced expert in the field of computer systems qualification and validation.
Good understanding of Annex 11, GAMP5 and Data Integrity Guidance.
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