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Job Details

PW-6845 Senior Manager/Associate Director IT Quality Assurance

Company: AXESS
Location: Surrey
Reference: PW-6845
Closing Date: 17 Dec 17
Type: Permanent
Salary (£): Competitive
Benefits: Corporate

Job Summary:

This is a key role within a leading global pharma company with responsibility for quality technology aspects across the clinical development phase to aid commercial readiness. This will include key IT system validation projects and system auditing. You will be part of an international EMEA quality group with a large number of affiliates and broad development pipeline across multiple therapy areas.

Requirements:

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

 

Apply for this job:  PW-6845 Senior Manager/Associate Director IT Quality Assurance

Contact Information:

Address:  Head Office
Isabella House,
12 Union Court,
Richmond upon Thames,
Surrey
TW9 1AA
England
Tel:  +44 (0)20 8560 2300
Fax:  +44 (0)20 8560 2033
Website:  Visit Our Web Site

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