Job Description
About The Role
We have an exciting opportunity for a Qualified Person to join our client on a full time permanent basis. This role is based in the UK.
We are ideally looking for an experienced Qualified Person, with management experience and responsibility for a Quality Management System. It is preferable that you have experience as a releasing QP within Radiopharmaceuticals/ steriles on a UK MHRA licence.
This role covers batch release of Radiopharmaceuticals for use in diagnostic PET scanning and contributing to the management of QMS.
Other key responsibilities of the role include:
- Overseeing the release of medicinal products for distribution, ensuring compliance with all relevant regulations and guidelines
- Reviewing and approving batch records, analytical data, and other documentation related to the manufacturing and testing of medicinal products
- Investigating and resolving quality issues and deviations related to manufacturing processes and materials
- Participating in internal and external audits of the manufacturing facilities and quality systems
- Providing expertise and guidance on regulatory requirements and quality standards to internal teams
Skills & Experience
The ideal candidate for this role will have a strong background in pharmaceutical manufacturing, quality assurance, and regulatory compliance, and have excellent attention to detail and problem-solving skills.
As a minimum you should hold a third level qualification in a scientific discipline – pharmacy, medicine, chemistry, pharmaceutical chemistry and biology.
In addition, must have fulfilled the education requirements for the role of the Qualified Person such as a diploma in Pharmaceutical Manufacturing Technology.
Previous Experience.
A minimum 3 years practical experience in activities of quantitative and qualitative analyses of active substances and of the necessary testing and checking to ensure the quality of medicinal products.