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Catalent are currently recruiting for a Senior Quality Associate to join our Swindon Manufacturing site. The Senior Quality Associate will manage and lead the continual improvement activities of the Quality Department by facilitating a continual improvement culture and leading project groups to execute the necessary improvements.

The role:

• Support the Head of QMS & Compliance in reviewing and quality approving a variety of quality and validation records.
• Developing a Continuous Improvement culture within the Quality Function and developing the QMS toward optimum efficiency.
• Provide Quality Continuous Improvement support to the implementation of new systems and upgrades to existing systems where necessary. Lead small team working opportunities to simplify systems,
• Supporting the development and execution of strategies to strengthen the Quality support to other departments such as manufacturing and engineering operations.
• Work together with other departments on improvement projects providing Quality insight and support.
• Challenge constraints on operations to remove illogical activities or non-value add process steps.
• Leading joint initiatives with key customers that aim to develop Operational/Quality performance
• Assist in conducting GMP, Quality Systems, SOP writing and GDP training for the site for new employees.
• Pathwise Training – DMC
• Support in the Internal Audit Program
• Support with Customer and Regulatory Audit preparation and Customer Audit hosting.
• Quality representation in facility and product risk assessments.
• To perform any other duties that may be required by line management.

The candidate:

• Demonstrated expert knowledge in the use of appropriate Quality Electronic Systems.
• Expert knowledge and understanding of the requirements for Data Integrity.
• Demonstrated technical competency.
• Demonstrate expert problem solving and analytical thinking skills.
• Quality input and review of documents, reports and protocols.
• Demonstrate ability for attention to detail.

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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.