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QA/RA Manager.

Reference Number: 924751 | Salary: Competitive | Location: West Sussex, United Kingdom | Division: Scientific Permanent


QA/RA Manager (Pharma / Medical Devices)
West Sussex – Medical Devices
Competitive Salary


Our client is a fast growing and well established medical device business with many years’ experience in being a specialised manufacturer. Due to continued growth in the business our client is now looking for a QA/RA Manager to join their team.

This role will be responsible for covering General Medicines (prescription) products, working on Life Cycle Management (renewals/variations) in the Europe markets, with opportunities to learn/support Pre-Approval applications (includes Clinical Trial Applications). The responsibilities will also include similar products but classified as medical devices.


Responsibilities

  • Ensure all GDP activities are fully compliant with regulations and Wholesaler dealing licence is retained.
  • Undertake the role of deputy Responsible Person (RP) as defined by the guidelines on GDP practice of medicinal products (2013/C 343/01)
  • To ensure that the operations team fully support the wider business through organising resources and processes and the quality of medicines and medical devices are supplied.
  • Ensure the company is fully compliant with all relevant EU, FDA, and National Quality regulations. These include ECGMP Directive (2003/94/EC), the related EEC-GMP-Guide as well as all appertaining EC guidelines and (ICH) as required.


Experience

  • Direct experience in a similar role in an SME, covering the creation, maintenance and submission of pharmaceutical registration documents
  • Experience as a Quality System leader in the pharmaceutical industry.
  • Experience of sterile pharmaceutical products

 

 

Please click apply now!


Harris Lord is acting as an employment agency for this role

 

 


Contact: Adrian Hole

Keywords: QA/RA, Quality Assurance, Quality, Regulatory, ISO13485, 13485, GDP, sterile, pharma, pharmaceuticals, RP, responsible person, GMP, FDA


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