Qualified Person
AssureBio have partnered with an exciting Pharmaceutical Company based in Yorkshire who are looking to hire a Qualified Person to support batch certification and to act as the Quality Assurance lead on the manufacturing site.
The organisation develops and produce innovative medicines which are vital to treat thousands of cancer patients across the UK. The Qualified Person will work with the Head of Quality, other QPs and Site Management to ensure the Local and Global Quality System operates in accordance with GMP.
Main Duties
- To undertake the duties of Qualified Person- terminal sterilisation and aseptic manufacturing methods
- To review and evaluate batch records and perform batch certification and release in accordance with Good Manufacturing Practice and the Marketing Authorisation / Clinical Trial Authorisation as appropriate.
- Work with the Head of Quality and other QPs in maintaining and improving the Global Quality system
- Review and approval of deviations, complaints, CAPAs, change controls and out of specification investigations
- To act as coach and mentor to the site team in aspects of Quality and Continual Improvements.
- Training of site staff in QMS requirements
- Develop and maintain good working relationships with all site staff, QPs and the Inspectorate
Qualifications/Experience
- Eligible to be nominated as a Qualified Person EU Directive 2001/83/EC as amended (Medicinal Products for Human Use)
- Previous experience in a pharmaceutical manufacturing organisation, ideally with sterile products
- Experience of line and performance management (QA/QC)