Deviation and Compliance Expert
4 weeks ago
Catalent is seeking a highly skilled Deviation and Compliance Specialist to join our Operations team in Swindon. This role will be responsible for driving investigation and technical write-up of operations deviations, including laboratory manufacturing investigations.
Key Responsibilities:- Categorize and write up deviations in accordance with company procedures.
- 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 to ensure batches are expedited to QA/QP review in line with the daily requirements of the batch tracker.
- 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 and associated paperwork prepared.
- Report writing experience.
- Experience using Microsoft Office, including Word, Excel, and PowerPoint.
- Strong administration skills, including good attention to detail.
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.
At Catalent, we value diversity and inclusion. We are an Equal Opportunity Employer and do 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, please submit your request by sending an email to. 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.
Catalent is committed to providing a safe and healthy work environment for all employees. We are an Equal Opportunity Employer and do not discriminate based on any characteristic protected by local law.
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Deviation and Compliance Expert
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Swindon, Swindon, United Kingdom Catalent Full timeJob Title: Deviation and Compliance SpecialistCatalent is seeking a highly skilled Deviation and Compliance Specialist to join our Operations team in Swindon. This role will be responsible for driving investigation and technical write-up of operations deviations, including laboratory manufacturing investigations.Key Responsibilities:Categorize and write up...
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Deviation and Compliance Expert
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Swindon, Swindon, United Kingdom Catalent Full timeJob Title: Deviation and Compliance SpecialistCatalent is seeking a highly skilled Deviation and Compliance Specialist to join our Operations team in Swindon. This role will be responsible for driving investigation and technical write-up of operations deviations, including laboratory manufacturing investigations.Key Responsibilities:Categorize and write up...
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Swindon, Swindon, United Kingdom Catalent Full timeJob SummaryCatalent 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 ResponsibilitiesCategorize and write up deviations, ensuring accurate and timely documentation.Address QP and...
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