Quality Assurance Specialist
£ Competitive salary and benefits package
Scope of role:
Responsible for the development and maintenance of a Quality Management System at a busy and collaborative production site for gene and cell therapeutics. You will assist in the development of internal measures and requirements of the governing bodies, to ensure a consistent and structured method of tracking all quality documentation.
- Acting as primary point of contact for both internal stakeholders and associates based on site
- Strategic development of the QMS, suggesting improvements as necessary and taking feedback about the user-interface
- Regular interaction with the regulatory bodies, development of governance structures particular to cell and gene therapy/manufacturing
- Prepare for regulatory agency and client inspections
- Act as Quality SME for the busy site
- Signpost internal staff and associates to best practice Quality behaviours
- Take part in the GMP internal audit programme - including corrective actions, and remedial actions to ensure quality improvements are met
- Your background will include working in Quality in aseptic manufacturing environments (ideally biologics, but other areas can be considered)
- Proven background of building and establishing GMP based quality systems
- It would be helpful to have worked in an R&D setting, ideally with regulatory authorities such as FDA and EMA, and a good awareness of ISO 9001.
- Highly motivated and team-spirited, comfortable working autonomously, working to deadlines and owning project management and outcomes
Does this sound like it could be the ideal next step for you?
Do you have a proven Quality management background?
Do you come from a biologics, pharma or medical device background?
Contact Bec Johnston: email@example.com / 01223 607858
your application has been submitted