Qualified Person

Swindon - UK

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Qualified Person

37.5 hours per week compressed hours available including weekend options.
100% on site at Swindon

Catalent Pharma Solutions Swindon is home to the worlds best-in-class ODT technology Zydisa 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 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.
CrossFunctional Quality Leadership Partner with QA QC Operations Supply Chain and Engineering to drive a strong quality culture.
ShopFloor Presence & Continuous Improvement Maintain operational visibility identify risks early and contribute to improvement initiatives.

The Candidate:

Fully Qualified Person (QP) under UK legislationwith 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 compliancewith solid knowledge of EU/UK GMP ICH guidelines MHRA expectations and QRM principles.
Experienced in investigations rootcause analysis and CAPA managementensuring robust and compliant resolution of quality issues.
Strong technical capability in reviewing GMP documentationincluding validation packages change controls and electronic batch records.
Confident supporting regulatory inspections and customer auditsdemonstrating high standards of compliance and operational readiness.
Skilled at interpreting complex data and making sound riskbased quality decisionseven under pressure.
Effective communicator and influencerable to work across all levels and foster a strong culture of quality and continuous improvement.
Organised calm and collaborative leaderwith the ability to coach teams manage multiple priorities and build strong crossfunctional 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 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. 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 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.

Qualified Person37.5 hours per week compressed hours available including weekend options.100% on site at SwindonCatalent Pharma Solutions Swindon is home to the worlds best-in-class ODT technology Zydisa unique fast-dissolving formulation that disperses almost instantly no water needed. With 20 prod...