1 день назад
Qualified Person and Responsible Person - UK
Мэтч & Сопровод
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Описание вакансии
Текст:
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
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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