QA Officer (Operations)
Confirmed live in the last 24 hours
Catalent
Job Description
QA Officer – Operations (24/7 Shift Pattern)
Location: Swindon
Position summary: Shift‑based role,
07.00 - 19.00 x2, 19.00 - 07.00 x2
As a key member of the Quality Assurance Operations team at Catalent, Swindon, the QA Officer will provide on‑line quality support to manufacturing activities, ensuring products are manufactured, documented, and released in full compliance with cGMP and Data Integrity requirements. This role is critical to building and demonstrating quality assurance across Zydis production operations, supporting both product quality and continuous GMP improvement.
The Role:
- Fulfil QA Officer duties in line with the QA Operations Standard of Work and as agreed with the Line Manager.
- Review batch manufacturing documentation, including EBRs, and liaise with Production to resolve and clarify issues.
- Provide an on‑line Quality presence within the production area, performing live document and product checks and supporting production quality enquiries.
- Escalate and communicate any quality or material‑related concerns to Line Management.
- Perform QA sign‑off following line set‑up to confirm manufacture is aligned with batch documentation and SOP requirements.
- Promote and personally uphold Data Integrity principles in line with ALCOA+ expectations.
- Perform QA checks of printed batch manufacturing records prior to issue to Production.
- Participate in Gemba walks within the production area in line with agreed schedules.
- Conduct batch record Stage Approvals as part of the batch release process.
- Perform quality review and approval of minor deviations.
- Work collaboratively with Production Management to drive improvements in GMP compliance across all shifts.
- Contribute to the 24/7 QA coverage of Zydis Manufacturing by working an agreed shift pattern.
- Uphold Catalent’s values by maintaining the highest ethical and professional standards.
- Perform additional duties as requested by your Line Manager.
The Candidate:
- Previous experience working in a QA, GMP, or regulated manufacturing environment (pharmaceutical, biotech, or FMCG).
- Strong working knowledge of cGMP and quality systems within production operations.
- Experience reviewing batch documentation and supporting manufacturing activities (desirable)
- Confident working within a fast‑paced environment.
- Strong attention to detail with effective communication and collaboration skills.
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 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.
