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We have an exciting opportunity for a Qualified Person to join us at Alliance Medical. This is a full time role working 40 hours a week on a permanent basis. We are ideally looking for an experienced Qualified Person, with management experience and responsbility 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.
Job Responsibility:
Batch release of Radiopharmaceuticals for use in diagnostic PET scanning
Contributing to the management of QMS
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
Requirements:
Third level qualification in a scientific discipline (pharmacy, medicine, chemistry, pharmaceutical chemistry, biology)
Fulfilled education requirements for the role of Qualified Person (e.g., diploma in Pharmaceutical Manufacturing Technology)
Minimum 3 years practical experience in quantitative and qualitative analyses of active substances and necessary testing to ensure quality of medicinal products
Experience as a releasing QP within Radiopharmaceuticals/steriles on a UK MHRA licence (preferable)
Management experience and responsibility for a Quality Management System
Strong background in pharmaceutical manufacturing, quality assurance, and regulatory compliance
Excellent attention to detail and problem-solving skills
Nice to have:
Experience as a releasing QP within Radiopharmaceuticals/steriles on a UK MHRA licence
Management experience and responsibility for a Quality Management System