Qualified Person (QP)

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 compliance. In 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 & Background

• Demonstrable experience and sound knowledge of GMP regulations.

• Competence in both written and verbal communication.

• Good organizational skills.

• Ability to interact with personnel at all levels from a variety of disciplines.

• Strong follow-up skills and attention to detail.

• Ability to be decisive regarding material and quality issues.

• Ability to work independently.

Why You Should Join Catalent

• With nearly 25 years of experience, our Bathgate location in Scotland, UK is an integral part of Catalent's European clinical supply services network, offering a comprehensive range of capabilities including clinical supply management, packaging, and QP release services.

• Competitive Salary - Reflecting your experience and skills.

• Benefits - A pension scheme matching up to 7.5% and life assurance. Enjoy BUPA private medical insurance, a generous holiday entitlement that increases with tenure, and the option to trade leave.

• Career Development - Access high-quality training, mentoring, and cross-functional opportunities within Catalent's global network. Benefit from a subscription to LinkedIn Learning, providing access to 10,000+ online courses.

• Health & Wellbeing - Includes an employee assistance programme, on-site canteen facilities, and an active safety and "Patient First" culture. Join Employee Resource Groups that foster a diverse and inclusive workplace. Plus, participate in charitable activities.

• Excellent Location - Just a few minutes' drive from J3A of the M8, with free on-site parking.