Qualified Person (QP)
Catalent ·
Position Summary We have an opportunity for a Qualified Person to join our team and take responsibility for ensuring the highest standards of quality and this role you will provide GMP oversight and certify products before release ensuring adherence to EU GMP regulations and Catalent policies.
You will collaborate with internal teams and clients to resolve quality issues and support batch release activities. This position requires a strong focus on patient safety product quality and regulatory compliance. Shift: 37 hours per week - 3 days minimum on site.
Location: Bathgate UK The Role Certify and release IMP and marketed product batches ensuring all GMP and regulatory requirements are met prior to distribution. Review and approve GMP documentation including batch records deviations investigations and other quality records.
Ensure ongoing compliance with the Quality Management System and applicable EU GMP regulations. Assess approve and support deviation complaint and quality investigation activities to ensure timely resolution. Collaborate with internal quality technical and operational teams to resolve batch release issues and drive compliance improvements.
Review approve and release Standard Operating Procedures (SOPs) and other controlled quality documents. Act as the key quality contact for clients manufacturing/testing sites and other Catalent locations on batch release and regulatory matters.
Participate in product recall activities quality improvement initiatives and cross-functional meetings while promoting a strong culture of GMP compliance and safety. The Candidate Minimum Requirements Qualified Person in accordance with Directive 2001/20/EC and/or Directive 2001/83/EC.
Bachelor of Science or equivalent in a relevant scientific discipline such as Chemistry or Biology. Clinical trial experience is preferred. Experience in biotechnology is preferred. Preferred Skills