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