Qualified Person (QP)

Catalent; Swindon; On-site; GBP 75,000 - 95,000; Full time

Benefits offered by this job

Site bonus

Pension up to 8%

Life assurance

Holiday entitlement growth

LinkedIn Learning access

Employee discounts

Cycle to work

EV car scheme

Job summary

Catalent Swindon site seeks a Qualified Person to certify and release batches in line with UK/EU GMP and internal standards. You will review batch records, analytical data, and supporting docs, ensuring products meet approved specs and procedures while leading quality across multiple functions.

The role involves handling deviations, investigations, CAPAs, and quality events, supporting audits, and contributing to continuous improvement initiatives. Onsite Mon-Fri, Swindon, UK.

Qualifications

• Qualified Person status under UK legislation.
• Degree in Life Science discipline.
• Extensive Good Manufacturing Practice pharmaceutical manufacturing experience.
• Expertise in batch certification and regulatory compliance.
• Strong knowledge of UK/EU GMP, ICH, and MHRA requirements.
• Proven experience in investigations and CAPAs.
• Track record supporting audits/regulatory inspections.
• Experience reviewing technical documentation, validation, and change controls.
• Strong analytical and quality decision-making skills.
• Experience with electronic quality systems.

Responsibilities

• Certify and release batches in line with UK/EU regulations and internal standards.
• Review and approve batch records, analytical data, and supporting documentation.
• Ensure products are manufactured, tested, and validated per specifications and procedures.
• Oversee deviations, complaints, investigations, CAPAs, and quality events with compliant resolutions.
• Review and approve GMP documentation, SOPs, validation protocols, change controls, and PQRs.
• Support internal and external audits, supplier qualification activities, and regulatory inspections.
• Provide quality leadership across QA, QC, Operations, Supply Chain, Engineering, and cross-functional teams.
• Support new product introductions, tech transfers, process changes, and continuous improvement.
• Make final risk-based decisions on batch release, rejection, or rework, maintaining oversight.

Skills

QP status

GMP experience

Batch release

Regulatory knowledge

Audits

Root cause analysis

Documentation review

Cross-functional collaboration

Leadership programs

Quality decision making

Education

Life Science degree

Job description

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.

Position Summary

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

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.

• 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 p