Senior Quality Associate

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) committed to helping people live better, healthier lives. We partner with pharmaceutical, biotech, and consumer health companies to support product development, launch, and full life-cycle supply. With over 40 global sites and thousands of scientists and technicians, Catalent delivers billions of doses of life-enhancing and life-saving treatments annually.

We are currently recruiting for a **Senior Quality Associate**to join our Swindon manufacturing site. The Senior Quality Associate will play a pivotal role in ensuring the integrity and compliance of batch manufacturing records. This position is key to supporting final QP certification and driving continuous improvement across our GMP operations

**The Role**:

- ** Batch Record Review**: Ensure accuracy and completeness of electronic and paper-based batch documentation
- ** Cross-Team Collaboration**: Work closely with QAO and production teams to resolve discrepancies and clarify documentation issues
- ** Quality Support**: Provide expert guidance to QAO and DDMC teams
- ** Issue Escalation**: Flag critical concerns to line management and Qualified Persons (QPs) promptly
- ** Corrective Actions**: Recommend and coordinate follow-ups with senior production, development, and QA staff
- ** Stage Approval**: Conduct batch record reviews as part of the release process
- ** Self-Inspections**: Perform audits of production areas and site systems per schedule
- ** GMP Compliance**: Partner with production management to strengthen compliance standards
- ** Continuous Improvement**: Contribute to initiatives that enhance quality and efficiency
- ** Project Leadership**: Support and lead cross-functional projects
- ** Workflow Optimisation**: Simplify and improve processes within the Quality function
- ** Regulatory Awareness**: Stay informed on industry regulations and technical developments
- ** Professional Conduct**: Uphold ethical standards and comply with Health & Safety policies
- Worked within a GMP environment
- Experience of batch record review
- Proficiency in Quality Electronic Systems
- Strong grasp of Data Integrity principles
- Proven analytical and problem-solving capabilities
- Exceptional attention to detail
- Clear and confident communication (verbal and written)

**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.

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.