Qualified Person (QP)

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

• 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.

• 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 Catalentsponsored leadership programs such as NGGL GOLD LEAD Now GM Excellence and GROW) may be considered in place of external experience.

• 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.

• 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 Catalents global network. Benefit from a subscription to LinkedIn Learning providing access to 10000 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 7000 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 70 billion 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.

Visit Catalent Careers to explore career opportunities.

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 . 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.