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Deviation and Compliance Expert

2 months ago

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Job Summary

Catalent is seeking a highly skilled Deviation and Compliance Specialist to join our Operations team. This role will drive investigation and technical write-up of operations deviations, including laboratory manufacturing investigations.

Key Responsibilities
  • Categorize and write up deviations, ensuring accurate and timely documentation.
  • Address QP and customer queries regarding deviations and batch record amendments.
  • Support audit readiness preparation by attending routine Gembas or specific tasks and internal/external audits, and collecting 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.
  • Manage deviation flow throughout the Zydis manufacturing department, ensuring batches are expedited to QA/QP review in line with daily requirements.
  • Be the customer contact (alongside relevant QP/QA associate) for all customer questions/concerns regarding deviations.
  • Provide expert process knowledge to the operations team to assist with deviation.
  • Ensure operations temporary change controls are raised and managed effectively, and reprocessing activities are clearly communicated with associated paperwork prepared.
Requirements
  • Report writing experience.
  • Experience using Microsoft Office, including Word, Excel, and PowerPoint.
  • Strong administration skills, including good attention to detail.
About Catalent

Catalent is a global drug development and delivery leader, advancing 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. Join us in making a difference.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.