QA Officer (Operations)

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.