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Interim Quality Systems Specialist

Job Title

Interim Quality Systems Specialist

ReferenceJ10400_653295
Recruiter1st Executive
Industry SectorManufacturing, Manufacturing - Other
Salary£300 to £400 per day
Town/CityNorth London
LocationsGreater London, Humberside & East Yorks, London, North Yorkshire, South Yorkshire, West Yorkshire, Yorkshire & Humber
Contract TypePermanent or Interim
Job CategoriesSupply Chain Jobs
Date Posted28 June 2017

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1st Executive are currently working with a multi-national FTSE 100 manufacturing business.

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.

Role: The jobholder will be responsible for the development of strategies and processes to implement and maintain a risk based software validation programme for the business. You will be responsible for ensuring that each site maintains compliance with all relevant regulatory and industry requirements including GMP (good manufacturing processes), QSA (quality systems regulations), FDA (food and drug administration), ISO (International Organisation for Standardisation) & IMDR (international medical device regulations).

Furthermore you will be responsible for providing technical support to the sites for any audits involving validations or observations around software validation.

Role requirements:
  • 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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