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Salary Role Overview:
We are currently looking for a Qualified Person to join a leading Pharmaceutical company based in the Bedfordshire area. As the Qualified Person you will be responsible for ensuring all medicinal product produced at our clients GMP compliant manufacturing site is in total compliance of the MHRA, along with MIA set-ups. This role is a part-time position, 1-2 days per week on-site.
Key Duties and Responsibilities:
Your duties as the Qualified Person will be varied however the key duties and responsibilities are as follows:
1. Undertake batch release of all medicinal products produced at the site ensuring compliance with appropriate GMP standard and Marketing Authorisation as well as hosting site audits undertaken by regulatory bodies and customers of medicinal products in conjunction with the site Quality Manager
2. Implement and support QMS practises, systems and procedures which ensure that regulatory activities relating to EU GMP Annex 16 batch release certification are undertaken and completed within acceptable time frames, and in total compliance of regulatory and customer specified requirements
3. As a Qualified Person you will ensure that all Parallel Import batches are reviewed and released according to MHRA guidelines.
4. Provide guidance and technical assistance for new product introduction and technical transfer of medicinal products and ensure the Site Master File is maintained and in compliance with GMP expectation.
Role Requirements:
To be successful in your application to this exciting opportunity as the Qualified Person we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (i.e Chemistry / Pharmaceutical Chemistry / Quality Assurance / Pharmaceutical Management) as well as is eligible to practise as a Qualified Person (QP) n the UK as defined within the UK/EU regulations.
2. Proven industry experience working with non-sterile medicinal products and MIA set up experience as well.
3. A working knowledge of batch release and QMS.
Key Words: Qualified Person / Pharmaceutical Quality Assurance / Batch Release / Quality Leadership / QP / Quality Management Systems / Importation / MIA
