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 Deviation and Compliance Specialist to join our team and play a key role in managing deviation investigations and supporting quality operations. You will work closely with Operations, QA, and QP teams to ensure timely and compliant resolution of quality events. This position offers the chance to contribute to continuous improvement and uphold the highest standards of quality and safety. You will be part of a collaborative environment that values professionalism, integrity, and excellence.
Shift: Monday - Friday 37.5 hours per week. Flexi between; 07.00 - 19.00
Location: Swindon, UK
100% Onsite
Operate within a manufacturing environment where PPE is mandatory .
The Role
Manage deviation investigations from categorisation through to closure, providing coaching and feedback to Operations teams.
Support QP, customer, and operational queries relating to deviations, batch record amendments, and quality events.
Maintain deviation workflow across the manufacturing department to ensure timely QA/QP review and batch release.
Coach teams on root cause analysis (RCA), deviation categorisation, and quality processes.
Prepare for internal, external, and customer audits, supporting audit readiness activities and follow-up actions.
Act as a customer contact for deviation-related enquiries alongside QA and QP colleagues.
Provide technical and process expertise to support investigations and issue resolution.
Oversee temporary change controls and reprocessing activities, ensuring effective communication and documentation.
Identify and implement opportunities for process and compliance improvements.
Promote safe working practices and compliance with Health & Safety requirements.
Uphold the highest standards of quality, ethics, and professionalism in line with company values.
Undertake other reasonable duties as required by the Line Manager.
The Candidate
Minimum Requirements
IT literacy with proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
Knowledge of pharmaceutical Good Manufacturing Practice (GMP) requirements.
Understanding of change control processes and associated quality systems.
Ability to write clear and concise technical reports.
Operate within a manufacturing environment where PPE is mandatory
Preferred Skills & Background
Communicate effectively with colleagues, customers, and stakeholders at all levels.
Foster an open and collaborative environment that supports effective root cause analysis (RCA).
Apply strong analytical skills to assess issues and identify practical, business-focused solutions.
Influence and work collaboratively across functions to achieve operational objectives
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…