QA/RA Manager (Pharmaceuticals)

West Sussex
45000.00 - 60000.00 GBP Annual + GBP45000 - GBP60000/annum
11 May 2017
25 May 2017
Contract Type
Full Time
QA/RA Manager (Pharmacuticals) - RP (Responsible Person)
West Sussex - Medical Devices
Competitive Salary

Our client is a fast growing medical device business with over 60 years' experience in being a specialised manufacturer. Due to continued growth in the business and a recent move to new premises 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.

• 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 Rayner Pharmaceuticals 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.

• 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

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