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Computerised Systems QA Lead

Cambridge, CambridgeshirePermanent
£55,000 - £60,000 per annum
Job Reference: J5633080
Updated On: 31/03/2020
Status: Now Interviewing
Hyper Recruitment Solutions
Sectors: IS&T

Skills: IS&T - Systems Engineering, IS&T - Data Integrity

Job Information

Role Overview

We 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 Responsibilities

1. 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 Requirements

Experienced expert in the field of computer systems qualification and validation.

Good understanding of Annex 11, GAMP5 and Data Integrity Guidance.

PRINCE2 certified.
David Powell
Your Recruitment ConsultantDavid Powelldavid.powell@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.