Quality Associate

Catalent; Swindon; On-site; GBP 30,000 - 42,000; 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 Swindon is seeking a Quality Associate to support audits, inspections, and compliance activities, ensuring high-quality GMP standards. The role emphasizes continuous improvement, quality systems guidance, and adherence to regulatory requirements in a 100% onsite environment.

The position offers standard daytime hours (Mon-Fri) with a focus on maintaining compliant processes, data integrity, and a safe workplace as part of Catalent's global quality leadership in drug development and

Qualifications

• Degree or equivalent in a scientific discipline or relevant industry experience.
• Experience working within a GMP-regulated pharmaceutical/biotech environment.
• Knowledge of Quality Management Systems and quality processes.
• Ability to review technical and quality documentation accurately.
• Understanding of data integrity requirements and good documentation practices.
• Proven success working with cross-functional teams.

Responsibilities

• Support customer audits, regulatory inspections, and compliance assessments.
• Review corrective and preventive actions for effective resolution and closure.
• Participate in internal audits to assess compliance with quality systems and regulatory requirements.
• Drive continuous improvement and cross-functional projects to enhance quality and efficiency.
• Identify quality trends, risks, and recurring issues for proactive management.
• Provide guidance on quality systems and processes to colleagues.
• Maintain GMP compliance and uphold company procedures and values.
• Promote a safe working environment per HSE standards.
• Report hazards, incidents, and unsafe practices promptly.
• Undertake other duties as assigned by the Line Manager.

Skills

GMP experience

Quality systems

Cross-functional teamwork

Data integrity

Documentation review

Education

Science degree or equivalent

Job description

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 Quality Associate to join our team. In this role, you will support audits, inspections, and compliance activities to ensure high-quality standards are maintained. You will contribute to continuous improvement initiatives and provide guidance on quality systems and processes. This position plays a key part in maintaining compliance with Good Manufacturing Practice requirements and promoting a safe, ethical working environment.

Shift: Monday - Friday 09.00 - 17.00

Location: Swindon, UK

100% Onsite

The Role

• Support customer audits, regulatory inspections, and compliance assessments.
• Conduct independent reviews of Corrective and Preventive Actions and corrective actions to ensure effective issue resolution and timely closure.
• Participate in internal audits to assess compliance with quality systems, procedures, and regulatory requirements.
• Drive continuous improvement and cross-functional projects that enhance quality, compliance, efficiency, and business performance.
• Identify and elevate quality trends, risks, and recurring issues to support proactive quality management.
• Provide guidance and support to colleagues on quality systems and processes.
• Maintain compliance with Good Manufacturing Practice requirements, quality standards, company procedures, and organisational values.
• Promote a safe working environment by adhering to Health, Safety, Environmental, Security, and ethical standards.
• Report hazards, incidents, and unsafe practices in a timely manner.
• Undertake any other reasonable duties commensurate with the role as assigned by the Line Manager.

The Candidate

Minimum Requirements

• Degree, Higher National Diploma, Higher National Certificate, or equivalent in a scientific discipline, or relevant industry experience.
• Experience working within a Good Manufacturing Practice-regulated pharmaceutical, biotechnology, medical device, or similar environment.
• Knowledge of Quality Management Systems and quality processes.
• Ability to review technical and quality documentation accurately.
• Understanding of data integrity requirements and good documentation practices.
• Proven success working with cross-functional teams.

Preferred Skills & Background

• Attention to detail and accuracy.
• Analytical skills to identify risks and compliance issues.
• Strong communication with stakeholders, customers, and auditors.
• Effective organisation and ability to manage priorities.
• Collaborative approach across teams and functions.
• Confident decision-making and independent quality oversight.
• Problem-solving mindset with a focus on continuous improvement.
• Adaptability in a fast-paced, regulated environment.

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 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.

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 [e-mail]. This option is reserved for individuals who are required to accommodate 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.