Qualified Person (QP)

Catalent Pharma Solutions; Swindon; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Site performance bonus

Pension scheme 8% match

Life assurance

Generous holiday entitlement

LinkedIn Learning access

On-site canteen

Job summary

Catalent is seeking a Qualified Person to lead batch release at our Swindon site, ensuring compliance with UK/EU GMP and internal standards. The role involves reviewing batch records, supporting investigations and CAPA, and coordinating across QA, QC, Operations and Engineering.

You will certify releases, support audits, and drive continuous improvement while keeping up-to-date with regulatory requirements. This is an on-site, standard daytime shift in Swindon, UK.

Qualifications

• Qualified Person status under UK legislation.
• Degree in a Life Science discipline.
• Extensive GMP pharmaceutical manufacturing experience.
• Expertise in batch certification and regulatory compliance.
• Strong knowledge of UK/EU GMP, ICH, and MHRA requirements.
• Experience in investigations, root cause analysis and CAPA.
• Track record supporting audits and regulatory inspections.
• Reviewing technical documentation, validation and change controls.
• Strong analytical and quality decision-making abilities.
• Experience with electronic quality systems.

Responsibilities

• Certify and release batches in compliance with UK/EU regulations and internal standards.
• Review and approve batch records, analytical data, and supporting documentation for product disposition.
• Ensure products are manufactured, tested and validated per specifications and procedures.
• Oversee deviations, complaints, investigations, CAPA and quality events with effective resolution.
• Review and approve GMP documents, SOPs, validation protocols, change controls, and PQRs.
• Support internal and external audits, supplier qualification, and regulatory inspections.
• Provide quality leadership across QA, QC, Operations, Supply Chain, Engineering, and cross-functional teams.
• Support new product introductions, technology transfers, process changes and continuous improvement.
• Make final risk-based decisions on batch release, rejection or rework, maintaining oversight of critical activities.
• Maintain visibility within operations and stay current with regulatory developments.

Skills

Quality leadership

Cross-functional collaboration

Regulatory compliance

Investigations & CAPA

Audits & inspections

Documentation review

Analytical decision-making

Education

Qualified Person status (UK)

Degree in Life Science

Job description

Position Summary

Our Swindon facility houses our Zydis® fast dissolving tablet development and manufacturing operation as well as a CMC pharmaceutical analytical lab services unit that offers ASAP stability.

We have an opportunity for a Qualified Person to join our team and play a key role in ensuring product quality and compliance. You will be responsible for certifying and releasing batches in line with UK/EU regulations and internal standards. This position involves close collaboration across multiple departments to maintain the highest levels of quality and regulatory compliance. You will also support audits, investigations, and continuous improvement initiatives while providing quality leadership across the site.

Shift: Monday - Friday 09.00 - 17.00

Location: Swindon, UK

100% Onsite

The Role

• Certify and release batches in compliance with UK/EU regulations, Good Manufacturing Practice, and internal quality standards.
• Review and approve batch records, analytical data, and supporting documentation to support product disposition.
• Ensure products are manufactured, tested, and validated in line with approved specifications and procedures.
• Oversee deviations, complaints, investigations, Corrective and Preventive Actions, and quality events, ensuring effective resolution and compliance.
• Review and approve Good Manufacturing Practice documentation, including Standard Operating Procedures, validation protocols, change controls, and Product Quality Reviews.
• Support internal and external audits, supplier qualification activities, and regulatory inspections.
• Provide quality leadership across Quality Assurance, Quality Control, Operations, Supply Chain, Engineering, and other cross‑functional teams.
• Support new product introductions, technology transfers, process changes, and continuous improvement initiatives.
• Make final risk‑based decisions on batch release, rejection, or rework, maintaining oversight of quality‑critical activities.
• Maintain visibility within operations, stay current with regulatory developments, and undertake additional duties as required by the business.

The Candidate Minimum Requirements

• Qualified Person status under UK legislation.
• Degree in a relevant Life Science discipline.
• Extensive Good Manufacturing Practice pharmaceutical manufacturing experience.
• Expertise in batch certification and regulatory compliance.
• Strong knowledge of UK/EU Good Manufacturing Practice, International Council for Harmonisation, and Medicines and Healthcare products Regulatory Agency requirements.
• Proven experience in investigations, root cause analysis, and Corrective and Preventive Actions.
• Track record supporting audits and regulatory inspections.
• Skilled in reviewing technical documentation, validation, and change controls.
• Strong analytical and quality decision‑making skills.
• Effective cross‑functional collaboration and experience with electronic quality systems.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Preferred Skills & Background

• Respected leader with the confidence to act as the independent quality authority.
• Exceptional communicator, able to influence stakeholders at all levels.
• Sound judgement and integrity, with a strong risk‑based approach to decision making.
• Passion for coaching and developing teams while promoting quality ownership.
• Calm and decisive when managing quality issues and critical release decisions.
• Highly organised, with the ability to balance multiple priorities and deadlines.
• Collaborative mindset that builds strong relationships across functions and sites.
• Commitment to continuous learning and industry best practice.
• Hands‑on approach with strong shop‑floor engagement and operational focus.

Why You Should Join Catalent

• Competitive Salary – Reflecting your experience and skills.
• Bonus & Benefits – Includes a site performance bonus, a pension scheme matching up to 8% and life assurance.
• Enjoy a generous holiday entitlement that increases with tenure, with the option to purchase additional leave.
• Plus, gain access to Reward Gateway, offering discounts at many national retailers.
• 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.
• Take advantage of a Cycle to Work Scheme and an Electric Vehicle car scheme.
• Excellent Location – Just a two‑minute drive from J16 of the M4, with free on‑site parking.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference 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.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time‑tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.