4 дня назад
Qualified Person and Responsible Person - UK
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Qualified Person and Responsible Person - UK (Pharmaceutical Quality Assurance): Ensuring compliant importation, storage, transportation, and distribution of medicinal products in line with UK GDP, the Human Medicines Regulations, and Falsified Medicines Directive requirements with an accent on quality systems, distribution licensing, and regulatory oversight. Focus on managing deviations, complaints, recalls, supplier qualification, CAPAs, returned and falsified products, and 24/7 transport-related quality issues.
Location: Cambridge, UK; based in person at the Cambridge office
Company
Dr. Reddy’s develops and manufactures medicines, focusing on affordability, innovative treatment options, and unmet medical needs.
What you will do
- Implement and maintain the GDP Quality Management System and related documentation.
- Take ultimate responsibility for medicinal products manufactured in Europe and distributed under the Wholesale Distribution Authorization.
- Ensure compliance required to obtain and maintain the distribution license.
- Implement GDP training programs and keep personnel up to date with regulatory requirements.
- Authorize quality activities, manage deviations, complaints, recalls, CAPAs, self-inspections, and the qualification of suppliers, customers, and contractors.
- Oversee returned, rejected, recalled, and falsified products, shortage reporting, Falsified Medicines Directive compliance, and delegated responsibilities.
Requirements
- Master’s degree in Pharmacy, Pharmaceutical Chemistry, Life Sciences, or a related field.
- Eligible to act as a Qualified Person under applicable UK and EU regulations.
- Significant Quality Assurance experience in the pharmaceutical industry.
- Strong GMP and GDP expertise, auditing, and compliance knowledge.
- Analytical decision-making, stakeholder management, and excellent communication skills.
- Availability to work in person from the Cambridge, UK office and provide 24/7 availability for transport-related complaints and deviations.
Culture & Benefits
- Full-time position within the Quality Assurance function.
- Work alongside teams responsible for medicinal product distribution and regulatory compliance.
- Inclusive workplace focused on diversity, equity, and belonging.
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