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GDP Responsible Person - Pharmaceutical

Job LocationBolsover
EducationNot Mentioned
Salary55,000 - 70,000 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, as they embark on a rapid phase of expansion within the business.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:

  • Ensuring continual compliance with the companys authorized activities
  • Ensure the quality system is maintained in accordance to the cGxP guidelines.
  • Hosting regulatory inspections and client audits with support from the quality team
  • Ensure the pharmaceutical products and medical devices are procured, held, supplied or exported in compliance with GDP.
  • Ensure all complaints are handled in a timely manner.
  • Change controls, deviation management and investigation management, acting as SME and providing guidance to departmental management to ensure timely completion.
  • Performing risk assessments and communicating outcomes and driving remediation measures where required.
  • Approve new customers and suppliers and ensure all routine verification checks are up to date and completed on time.
  • Approve all completed return assessments
  • Ensure all quality agreements are implemented.
  • Be an active member of the company self-inspection program and work on continuous improvement carrying out corrective and preventive actions where required.
  • Providing initial and ongoing training as required, mentoring and developing members of the quality team and maintaining your own CPD.
  • Maintain oversight where any RP duties have been delegated.
The successful candidate for the Responsible Person role will have the following background:
  • An experienced RP 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, RP, GDP, WDA (H)

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