Deputy RP, Quality and Medical Affairs Manager

Clinical Research, Medical Affairs, Other, Medical Information/Writing

South East (Excluding London)

£70,000

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Reference: QAMAM_WE

* This Vacancy Has Now Expired *

Deputy RP, Quality Manager & Medical Affairs Manager



Star is looking for a candidate to fulfil a unique role that represents a blend of responsibilities across Quality Assurance and Medical Affairs. Familiarity in working with Quality Management Systems, handling CAPAs, and ensuring internal compliance to SOPs will be key elements of this role.



Position Purpose



  • Acting as deputy to the Quality Manager:

    • Maintaining the Quality System including documentation at the affiliate

    • Acting as deputy Responsible Person on the Wholesale Distribution Authorisation

    • Acting as deputy recall coordinator ensuring that the actions involved in recall are completed

    • Management of deviations, CAPAs, change controls, controlled documents, product technical complaints, internal and external audits and supplier management in the absence of the Quality Manager

    • Assisting with the final administrative release of all UK and Irish product batches on Dispatcher and SAP and associated processes



  • Responsible for the development and implementation of the Medical Affairs strategy in specific therapy areas and providing expert advice on the same within the business

  • Handling UK Medical Information queries, ZINC review and providing product specific and SOP training internally and externally as required

  • Ensuring that activities and processes are conducted to a high standard, consistent with:

    • ABPI Code of Practice

    • Pharmacovigilance requirements

    • Regulatory Guidelines

    • Current UK & EU prevailing laws (where applicable)

    • Company values





Education



  • Advance Life Science Degree/Pharmacy degree

  • Therapy area knowledge



Experience



  • Experience in pharmaceutical industry in quality assurance, Medical Information, Pharmacovigilance and/or Regulatory Affairs preferable

  • Experience of Good Distribution Practice and/or supply chain quality assurance

  • Experience of any of the following therapy areas: Immunology, Respiratory, Coagulation and Acquired Bleeding

  • Experience of writing and reviewing procedures



Apply for this opportunity now via this website, or call Will on 01628 581 240!




Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.


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