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Quality Product Specialist

I am currently working with an innovative Global Pharmaceutical company in South Buckinghmashire with an exciting product pipeline who are looking to treble in size in the next two years.

We are looking for a Quality Specialist to join the team to provide QA support for the manufacture of products commercialised within any of the Group of companies. You will be responsible for ensuring that each product is manufactured and supplied to the marketplace in compliance with cGMP requirements, Marketing Authorisations, company operating policies and procedures and business requirements.

Key Responsibilities:

To Write/ review of all GMP and technical documents and ensure the compliance with EU and US requirement

Position Requirements (knowledge, education, qualifications, number of years' experience, etc.)

  • A Life Science degree or equivalent preferable in microbiology.
  • A broad experience of working within the pharmaceutical industry of which several years will have been operating in a QA Management position at a sterile products/biologicals manufacturing site.
  • Excellent working knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials
  • Sound knowledge of QC and Stability chemical analytical testing techniques for Sterile/ biologics
  • Familiar with the regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cleaning procedures, computerised systems
  • Familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines

If this position is of interest to you or someone you know, please get in touch as soon as possible - interviews are already happening!

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales