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GDP Responsible Person / RP - Pharmaceutical

Job LocationDartford
EducationNot Mentioned
Salary55,000 - 65,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

We are supporting a well-established and leading business within the healthcare sector, with hiring for an experienced Responsible Person to join their team during a period of growth within this organisation.This Responsible Person hire is a part of a long-list of critical investments the business have made. You will be a key member of the compliance team, and have a real tangible as well as strategic input within a growing business. You will be accountablefor driving the culture of quality and compliance to the next level as the business continues to expand.The key responsibilities for the Responsible Person will involve:

  • To Ensure that the quality management system related to Good Distribution Practice is implemented and maintained as per the EU guidance on GDP (2013/C 343/01) and Human Medicines Regulation 2021.
  • To Ensure the management of authorised activities and quality records are maintained accurately.
  • To co-ordinate with manufacturers and promptly performing any recall operations.
  • To Ensure customer complaints are dealt effectively.
  • To Ensure all suppliers and customers are approved as per the procedures.
  • To approve any subcontracted activities which are relevant to GDP.
  • To Ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
  • To Ensure appropriate records are maintained of any delegated duties
  • To approve final disposition of returned, rejected, recalled or falsified products are dealt with effectively.
  • To approve any returns to saleable stock.
  • To ensure any additional requirements imposed on controlled drugs and unlicensed medicines maintained as per the regulations and procedures.
  • To Ensure effective training of the Trainee Responsible Person.
The successful candidate for the Responsible Person role will have the following background:
  • An experienced Responsible Person / GDP Quality Manager with a strong quality background currently working within industry.
  • A degree in a relevant Scientific discipline would be advantageous as would a number of years working within an established quality team in a pharmaceutical organisation.
  • Proven experience working as an auditor and development, implementation and maintenance of quality systems is essential.
Keywords: Responsible Person, Head of Quality, Quality Manager, RP, GDP, WDA (H)

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