Deviation and Compliance Specialist

Catalent Pharma Solutions; Swindon; On-site; GBP 42,000 - 60,000; Full time

Benefits offered by this job

Site performance bonus

Pension scheme matching up to 8%

Life assurance

Generous holiday entitlement

Reward Gateway discounts

Job summary

Catalent Pharma Solutions in Swindon seeks a Deviation and Compliance Specialist to lead deviation investigations and support quality operations. You will collaborate with Operations, QA, and QP teams to resolve quality events promptly and maintain high standards of safety and compliance.

The role emphasizes coaching on RCA, change control, and regulatory processes, with a focus on audit readiness and continuous improvement within a 37.5 hour week onsite, PPE required.

Qualifications

• Strong IT literacy with Microsoft Office.
• Knowledge of pharmaceutical GMP requirements.
• Understanding of change control processes and associated quality systems.
• Ability to write clear and concise technical reports.
• Operate in a manufacturing environment where PPE is mandatory.

Responsibilities

• Manage deviation investigations from categorisation through to closure.
• Support QA, 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.

Skills

Deviation investigations

QA processes

Root cause analysis

GMP knowledge

Change control

Documentation skills

Operational coaching

Job description

Position Summary

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 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

• 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 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.

Equal Opportunity Employer

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

Accessibility Statement

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 [e-mail]. 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.

Agency Notice

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.

About Catalent

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.