QMS Officer

Position Summary:

• Work Schedule: Monday – Friday 37.5 per week.

We are currently seeking a Quality Management System (QMS) Officer to support our Quality team in Swindon. You will maintain and enhance our QMS processes. This is a fantastic opportunity to contribute to a dynamic and innovative pharmaceutical environment.

The Role:

• Manage regulatory requests, including logging and generating quotes
• Prepare and write detailed reports
• Review and approve printed Batch Records before release to Manufacturing
• Log and author complaint reports
• Compile Annual Product Reviews
• Administer the Management of Change process
• Participate in internal audits of Catalent UK systems and procedures
• Ensure compliance with current EHS legislation and company standards
• Execute and document work in line with cGMP, business needs, and management direction
• Perform additional duties as assigned by line management

The Candidate:

• Excellent attention to detail
• Report writing skills (Essential)
• Experience in complaints and investigations (Advantageous)
• Proficient in Microsoft Excel and other Office applications – (Essential)

Why you should join Catalent:

• Competitive Salary – Reflecting your experience and skills.
• Working Hours - Monday to Friday 37.5 hours per week
• 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.

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 [email protected]. 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.