Ref #:
QPNW
Dal Pawar
21/12/2022
Location:
North West (UK)
Not Disclosed
North West (UK)
Salary:
£75,000-£95,000
£
Type:
Permanent
Seniority:
Mid/Senior Level
Specialisms:
Quality Assurance, Qualified Person, GMP
Date:
21/12/2022
Qualified Person- Northwest of England
AssureBio has partnered with an innovative pharmaceutical company in the Northwest of England region that is looking to recruit a Qualified Person to support batch certification and serve as the Quality Assurance lead on the production site.
The organisation develops and manufactures novel medicines that are critical in the treatment of 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.
This is aligned with the organization's ongoing dedication to quality and the provision of safe and effective goods to patients.
Main Duties
- 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
- Review and approval of Standard Operating Procedures and Forms
- Review and approval of qualification / validation protocols and reports
- Perform internal and supplier audits
- 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
- Attend site Quality Management Meetings and be proactive in addressing any issues identified
- Actively participate in MHRA inspections of the main site and other sites as required
- Perform line management responsibilities for subordinates as required, including management of workload and tasks required
- Promoting a quality culture across the site by liaising with cross functional teams
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 QP certification of medicinal products
- Previous experience in a pharmaceutical manufacturing organisation, ideally with sterile products
- Experience of line and performance management (QA/QC)
- High levels of attention to detail, with the ability to work efficiently in a fast paced environment