Senior QA Officer

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideasand passionare essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

An exciting opportunity has arisen for a motivated Senior Quality Assurance Officer to join our busy quality team at Catalent Pharma solutions Swindon. The Swindon facility houses our Zydis® fast dissolving tablet development and manufacturing operation as well as a CMC pharmaceutical analytical lab services.

This quality role is situated in the production facility. You will be part of a small, but extremely functional team of 13 individuals which is an eclectic mix of talent and experience. You will be joining a fast paced manufacturing environment with complex processes. As a new team member your learning will be continuously ongoing; getting the opportunity to experience and impact change transformation. You will be surrounded by people with years of Catalent experience under their belt, which will enable you to feel supported and allow you to shape your position and career within the team.

Change and Continuous Improvement is on forefront of Catalent’s mind. We want dynamic individuals with a passion to keep moving forward and always asking the question as to how can we improve and help to continue pushing the change journey.

Responsibilities;

• Review all batch documentation, including EBRs, liaising with production management to resolve and clarify any points of issue.

• Provide an “on-line” Quality presence in the production area during manufacture with particular regard to on-line document and product checks and quality support for production enquiries. To inform line management of any issues relating to the quality of product or materials.

• provide functional support and input into Tripartite meetings, thus ensuring timely critical thinking and decision making when problems are encountered

• Ensure that appropriate problem-solving methodology (e.g. Fishbone diagram, 5 Whys, RCA) is used as part of investigations to find true root cause and resolve business issues

• Follow up production events by recommending appropriate courses of action, if necessary by liaison with senior production, development and QA staff, ensuring that all actions are completed.

• Conduct batch record “Stage Approval” as part of batch release process

• Participate in Gemba walks of the production area and conduct specific site systems audits in accordance with the agreed schedule.

• Work with production management to drive improvements in GMP compliance across all shifts.

Requirements;

• Able to wear PPE

• Computer literate

• Adaptable to change

• Team player

• Able to challenge where necessary

• Able to follow written instructions and have a good standard of written English

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 www.catalent.com/careers to explore career opportunities.

C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 DisabilityAccommodations@catalent.com . 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.