Qualified Person (QP)

Catalent Pharma Solutions; Bathgate; On-site; GBP 65,000 - 75,000; Full time

Benefits offered by this job

Pension scheme matching up to 7.5%

Life assurance

BUPA private medical insurance

Generous holiday entitlement

Trade leave option

Job summary

Catalent Bathgate, UK is seeking a Qualified Person to oversee GMP compliance and certify products prior to release. The role involves reviewing GMP documentation, supporting deviations and investigations, and ensuring regulatory adherence across EU GMP regulations.

The successful candidate will collaborate with internal teams and clients to resolve quality issues, participate in recalls and continuous improvements, and contribute to a strong Patient First culture at Catalent.

Qualifications

• Qualified Person in accordance with 2001/20/EC and/or 2001/83/EC.
• Clinical trial experience preferred.
• Experience in biotechnology preferred.

Responsibilities

• Certify and release IMP and marketed product batches, ensuring 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 EU GMP regulations.
• Assess, approve, and support deviation, complaint, and quality investigations to ensure timely resolution.
• Collaborate with internal teams to resolve batch release issues and drive compliance improvements.
• Review and release SOPs and other controlled quality documents.
• Act as key quality contact for clients, sites, and Catalent locations on batch release and regulatory matters.
• Participate in product recall activities and quality improvement initiatives.

Skills

GMP regulations

Quality assurance

Regulatory oversight

Education

Bachelor of Science or equivalent

Job description

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.

personal initiative. dynamic pace. meaningful work.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives

Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.