QA/RA Manager (Pharma / Medical Devices)
West Sussex – Medical Devices
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.
- 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.
- 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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