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Qualified Person and Responsible Person - UK

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
UK
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR
Qualified Person and Responsible Person - UK (Pharmaceutical Quality): Overseeing GDP compliance for the importation, storage, transportation, and distribution of medicinal products in the UK with an accent on quality systems, regulatory licensing, and supply-chain controls. Focus on managing deviations, complaints, recalls, CAPAs, falsified medicines, supplier qualification, and 24/7 transport-related quality issues.

Location: Cambridge, UK; on-premise work from the Cambridge office

Company

hirify.global develops and supplies affordable medicines and innovative treatment options for unmet medical needs.

What you will do

  • Implement and maintain the GDP Quality Management System and documentation.
  • Oversee medicinal product importation, storage, transportation, and distribution under the Wholesale Distribution Authorization.
  • Authorize quality activities and records, manage deviations, customer complaints, recalls, returns, rejected products, and falsified medicines.
  • Approve suppliers, customers, and outsourced distribution activities, and manage self-inspections and CAPA implementation.
  • Implement GDP training and competency programs and communicate regulatory changes.
  • Maintain Falsified Medicines Directive procedures, report potential shortages, and document delegated responsibilities.

Requirements

  • Master's degree in Pharmacy, Pharmaceutical Chemistry, Life Sciences, or a related field.
  • Eligibility to act as a Qualified Person under applicable UK/EU regulations.
  • Significant Quality Assurance experience in the pharmaceutical industry.
  • Expertise in GMP/GDP, auditing, and compliance.
  • Strong analytical decision-making, stakeholder management, and communication skills.
  • Availability for transport-related complaints and deviations 24/7.

Culture & Benefits

  • Full-time employment within the Quality Assurance function.
  • Work in a diverse, equitable, and inclusive environment.
  • Opportunity to contribute to improving access to medicines and healthcare outcomes.

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