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