PW-6845 Senior Manager/Associate Director IT Quality Assurance

Recruiter
AXESS
Location
Berkshire
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
BACKGROUND Global organisation – top 20 pharma Excellent career development opportunities Fantastic, modern offices PRIMARY DUTIES Key responsibilities include: Coordinate and manage Computer systems validation activities toward compliance with the Quality System Regulations, including 21 CFR Part 10 and 11 Coordinate and manage towards cGMP compliance with the Quality System Regulation Global process validation management from clinical through to manufacturing phases Utilising the Trackwise QMS to provide a QA Management oversight of Clinical Trial Materials (CTM), comprising of supplier audits, deviation assessment, change controls, product release, 3rd party manufacturing and distribution components. QA Oversight of Technology Transfer Activities, validation of New Product manufacturing operations, commercial Manufacturing Readiness and PAI Readiness, products transfers and local manufacturing under license transfer activity QUALIFICATIONS / EXPERIENCE REQUIRED: Degree in a science/health-related subject IT GMP experience gained from the pharmaceutical sector Experience of being involved or leading IT system validation projects IT system auditing experience Ideally experience in data integrity from a quality (cGMP) perspective or at least an understanding of the area TO APPLY: For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300. To apply, please send your CV to jobs@axess.co.uk quoting reference PW-6845 KEYWORDS: Senior Manager ITQA, associate director ITQA, Senior Manager QA, associate director QA, Quality Assurance , QAIT, Quality technology, GMP, audits, auditing, Technology Transfer, Supplier audits, Deviation Assessment, validation, manufacturing, products transfers, CSV, Computer System Validation. Computer software Validation, quality systems, quality management systems, trackwise, New Product manufacturing operations, data integrity ABOUT AXESS: AXESS has been operating since 1990 We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development We match professional candidates to the best permanent, contract and interim roles in the market Visit us at www.axess.co.uk

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