Qualified Person37.5 hours per week, compressed hours available including weekend options.100% on site at SwindonCatalent Pharma Solutions Swindon is home to the world’s best-in-class ODT technology, Zydis®—a unique, fast-dissolving formulation that disperses almost instantly, no water needed. With 20+ products launched across 60 countries, we are redefining drug delivery.We are seeking an experienced and highly motivatedQualified Person (QP) to join our Quality Operations team. As a QP, you will play a critical role in ensuring that all medicinal products are manufactured, tested, and released in accordance with UK/EU legislation, GMP requirements, and the conditions of relevant Marketing Authorisations or IMP dossiers.Acting as the onsite representative of the MHRA, you will provide independent oversight, safeguard patient safety, and ensure the integrity of the quality system. This is a highly visible and impactful role with strong collaboration across Operations, QA, QC, Supply Chain, Engineering, and other key functions.The Role:Batch Certification & Compliance – Ensure all batches meet UK/EU GMP and regulatory requirements before release.Review & Approval of GMP Documentation – Assess batch records, analytical data, and key quality documents to support compliant manufacturing.Deviation, Investigation & CAPA Oversight – Provide independent oversight to ensure issues are thoroughly investigated and resolved.Audit & Inspection Support – Support internal audits and regulatory inspections by demonstrating strong compliance.Cross‑Functional Quality Leadership – Partner with QA, QC, Operations, Supply Chain, and Engineering to drive a strong quality culture.Shop‑Floor Presence & Continuous Improvement – Maintain operational visibility, identify risks early, and contribute to improvement initiatives.The Candidate:Fully Qualified Person (QP) under UK legislation,with a relevant Life Science degree and strong GMP pharmaceutical manufacturing experience/close to completing VIVA with relevant oral solid dosage pharmaceutical experience.Proven expertise in batch certification and regulatory compliance,with solid knowledge of EU/UK GMP, ICH guidelines, MHRA expectations, and QRM principles.Experienced in investigations, root‑cause analysis, and CAPA management,ensuring robust and compliant resolution of quality issues.Strong technical capability in reviewing GMP documentation,including validation packages, change controls, and electronic batch records.Confident supporting regulatory inspections and customer audits,demonstrating high standards of compliance and operational readiness.Skilled at interpreting complex data and making sound, risk‑based quality decisions,even under pressure.Effective communicator and influencer,able to work across all levels and foster a strong culture of quality and continuous improvement.Organised, calm, and collaborative leader,with the ability to coach teams, manage multiple priorities, and build strong cross‑functional relationships.Why you should join Catalent:Competitive Salary – Reflecting your experience and skills.Bonus & Benefits – Includes an annual performance bonus, a pension scheme matching up to 8% and life assurance. Enjoy BUPA private medical insurance, a generous holiday entitlement that increases with tenure, and 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. Join Employee Resource Groups that foster a diverse and inclusive workplace. Plus, participate in charitable activities.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 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 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.
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