Job description
An exciting opportunity has arisen for a motivated 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 15 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 we can improve and help to continue pushing the change journey.
Hours: Shift type; 4 on 4 off, 07.30 -19.30 & 19.30 – 07.30
The Role:
- To review all batch documentation, including EBRs, liaising with production management to resolve and clarify any points of issue.
- To provide a Quality presence in production and real time Quality support for production queries.
- To perform review of Trackwise deviations.
- To conduct batch record "Stage Approval" as part of the batch release process
- To provide functional support and input into manufacturing investigations using root cause analysis and other problem-solving tools as appropriate.
- To participate in Gemba walks of the production area and conduct specific site systems audits in accordance with agreed schedules.
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.