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Interim Quality Management Systems Specialist

Job Title

Interim Quality Management Systems Specialist

Recruiter1st Executive
Industry SectorFMCG - Non Food, Food Service, Catering, & Hospitality, Manufacturing, Manufacturing - Other, Pharmaceutical & Biotech, Services
Salary£300 to £325 per day
Town/CityEast Riding of Yorkshire
LocationsHumberside & East Yorks, North Yorkshire, South Yorkshire, West Yorkshire, Yorkshire & Humber
Contract TypePermanent or Interim
Job CategoriesOperations, Supply Chain Jobs
Date Posted09 June 2017

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1st Executive are retained by a global FTSE100 manufacturing organisation. They require an experienced quality management systems professional to join their organisation on an interim basis, ahead of some key process changes to their internal quality management IT solutions.

Job Purpose:

To manage and prepare quality management processes and procedures for existing systems and software validation.

Required experience:

Demonstrated experience of preparing quality management process procedures for computer system/software validation. Must have worked leading these activities.

Demonstrated experience of preparing instruction / guidance and requirement specifications for computer system/software validation and operational controls.

In depth working knowledge of the FDA, EU and ISO standards for GMP and Quality System Regulations. Demonstrated knowledge of all of these regulations:
  • FDA - 21 CFR Part 11, 210/211, 820 and recent guidance on Data Integrity.
  • EU - COUNCIL DIRECTIVE 93/42/EEC - Medical Device (Current Version) and awareness of REGULATION (EU) 2017/745, Also knowledge of Eudralex Volume 4 - Good Manufacturing Practice (GMP) guidelines including the Good Distribution Practice. Additionally knowledge of the MHRA Orange Guide.
  • ISO - 13485:2016 including updated requirements for computerised systems.

Working knowledge of the GAMP Guide Version 5 and the associated guidance documents from the ISPE.

Demonstrated ability to review existing computer systems qualification, validation and operational controls, perform gap assessments against corporate standards and regulatory requirements and to define remediation activities.

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Recruiter: 1st Executive
Tel: 0843 216 3030
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