Compliance and Deviation Specialist

4 weeks ago

Swindon, Swindon, United Kingdom Catalent Full time

Catalent is currently recruiting for a Deviation and Compliance Specialist to join the Operations team.

This role will drive investigation and technical write-up of operations deviations, including laboratory manufacturing investigations.

The role works closely with the operations team and support functions, including engineering, utilities, and quality.

The role also supports Compliance activities, including change controls, operations team coaching, and audit preparation.

Key Responsibilities:

  • 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.
  • Coaching and support the operations team on RCA and deviation categorization.
  • Day-to-day management of 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 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 deviation.
  • Ensure operations temporary change controls are raised and managed effectively and reprocessing activities are clearly communicated and any associated paperwork prepared.

Requirements:

  • 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.

Personal initiative. Dynamic pace. Meaningful work.

Visit to explore career opportunities.

Catalent is an Equal Opportunity Employer and does 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, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title, and location 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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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