Lead Qualified Person

AssureBio is working in partnership with an exciting pharmaceutical company to recruit a Qualified Person (QP) who will play a key role in batch certification of sterile medicinal products.

Main Duties

• To undertake the duties of Qualified Person
• 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

What's on offer:

• Competitive salary
• Bonus scheme
• Pension Scheme
• 25 days holiday
• Additional benefits