Job Reference: J5638384
Status: Now Interviewing
We are currently looking for a Qualified Person to join a leading Pharmaceutical company based in the Lancashire 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 manufacturer’s licence, UK\EU GMP regulation, Product Marketing Authorisation(s) and customer specified requirements. This position is working at a Manufacturing site with options of home based work, but is not a fully remote role.
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 their CPD record is maintained and updated with their appropriate Society of professional membership as well as assist the QA group with the supplier assurance audit programme for medicinal product excipients and components undertaking sites audits where required.
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 EU GMP expectation
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 product for both topical application and oral administration is expected as well as experience managing regulatory, customer and supplier meetings with a multi-discipline group of attendees.
3. A working knowledge and practical experience with Q-Pulse Quality Management System would be desirable.
Key Words: Qualified Person / Pharmaceutical Quality Assurance / Batch Release / Quality Leadership / QP / Quality Management Systems
Interested in this job? Apply for this position now!
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.