Compliance and Quality Assurance Specialist
10 hours ago
At Catalent, we are a global leader in the development and delivery of new medicines. Our Swindon facility is home to our Zydis fast dissolving tablet development and manufacturing operation, as well as a CMC pharmaceutical analytical lab services unit that offers ASAP stability.
We are currently seeking a Compliance and Quality Assurance Specialist to join our Operations team. This role will play a critical part in driving investigation and technical write-up of operations deviations, including laboratory manufacturing investigations.
The Role:
- Deviation categorization and write-up
- Addressing QP and customer queries regarding deviations and batch record amendments
- Supporting audit readiness preparation by attending routine Gembas or specific tasks and internal/external audits, and collecting follow-up actions
- Proactively identifying opportunities for process improvements
- Ensuring safe working practices are employed, monitored, and adhered to in line with the company Health and Safety policy
- Cross-functional coaching and support of the operations team on RCA and deviation categorization
- Day-to-day management of Deviation flow throughout the Zydis manufacturing department, ensuring batches are expedited to QA/QP review in line with the daily requirements of the batch tracker
- Customer contact (alongside relevant QP/QA associate) for all customer questions/concerns regarding deviations
- Providing expert process knowledge to the operations team to assist with deviation
- Ensuring operations temporary change controls are raised and managed effectively, and reprocessing activities are clearly communicated along with associated paperwork prepared
The Candidate:
- Report writing experience
- Proficiency in using Microsoft Office applications, including Word, Excel, and PowerPoint
- Strong administrative skills, including attention to detail
We offer a competitive salary of $80,000 - $100,000 per annum, based on location and experience, plus benefits such as health insurance, retirement plan, and paid time off. If you're passionate about advancing new medicines from early development to clinical trials and to market, and want to be part of a dynamic and growing international company, please explore career opportunities at Catalent.
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