Regulatory Compliance Expert
4 days ago
Catalent is a global drug development and delivery leader, offering rewarding opportunities to further your career. Our Swindon facility houses our Zydis fast dissolving tablet development and manufacturing operation as well as a CMC pharmaceutical analytical lab services unit that provides ASAP stability.
We are currently recruiting for a Regulatory Compliance Expert to join the Operations team. This role will drive investigation and technical write up of operations deviations, including laboratory manufacturing investigations. The successful candidate will work closely with the operations team and support functions, including engineering, utilities, and quality.
The Role:
- Deviation categorization and write up
- Address QP and customer queries regarding deviations and batch record amendments
- Support on audit readiness preparation by attending routine Gembas or specific tasks and internal/external audits and collection of follow-up actions
- Proactively identify opportunities for process improvements
- Ensure safe working practices are employed, monitored, and adhered to in line with the company Health and Safety policy
- Coach and support 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
- Be Customer contact (alongside relevant QP/QA associate) for all customer questions/concerns with regards to deviations
- Provide expert process knowledge to the operations team to help assist with deviations
- Ensure operations temporary change controls are raised and managed effectively and reprocessing activities are clearly communicated and any associated paperwork prepared
The Candidate:
- Report writing experience
- Experience using Microsoft Office, including Word, Excel, and PowerPoint
- Strong Administration skills, including good attention to detail
Estimated Salary: £45,000 - £55,000 per annum. Based on the location and industry standards, this salary range reflects the expected remuneration for this position.
About Catalent:
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. We produce over 70 billion doses per year, and each one will be used by someone who is counting on us.
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