Quality Associate

Catalent Pharma Solutions; Swindon; On-site; GBP 32,000 - 42,000; Full time

Benefits offered by this job

Site bonuses

Pension scheme matching up to 8%

Life assurance

Generous holiday entitlement

Cycle to Work

LinkedIn Learning access

On-site canteen

Employee assistance programme

Job summary

Catalent Swindon is seeking a Quality Associate to support audits, compliance, CAPAs and quality systems, ensuring GMP standards are met and operations run safely and ethically.

You will review documentation, participate in internal audits, drive continuous improvement projects, and provide guidance to cross-functional teams on quality processes in a fast-paced, regulated pharma environment. This onsite role offers a structured development path and benefits.

Qualifications

• Degree or equivalent in a scientific discipline with GMP exposure.
• Experience in GMP-regulated pharma, biotech, medical device, or similar.
• Knowledge of quality management systems and processes.
• Ability to review technical and quality documentation accurately.
• Understanding of data integrity and good documentation practices.
• Proven ability to work with cross-functional teams.

Responsibilities

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

Skills

Quality systems

Cross-functional collaboration

Documentation accuracy

Data integrity

Audits & inspections

Continuous improvement

Problem solving

Education

BSc / applied science or equivalent

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. 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.

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 [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.

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.

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.