Deviation and Compliance Specialist

TN United Kingdom; Swindon; On-site; GBP 35,000 - 55,000; Full time

Job summary

An innovative global leader in drug development is seeking a Deviation and Compliance Specialist to join their Operations team in Swindon. This role is crucial for investigating operational deviations and ensuring compliance with health and safety policies. The specialist will collaborate with various teams to identify process improvements and support audit readiness. With a commitment to meaningful work, this company values personal initiative and offers rewarding career opportunities. Join a dynamic environment where your contributions can make a real difference in the lives of patients worldwide.

Qualifications

• Strong administrative skills with keen attention to detail.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).

Responsibilities

• Investigate operational deviations and prepare detailed reports.
• Ensure adherence to health and safety policies in the workplace.
• Coach the operations team on root cause analysis.

Skills

Microsoft Office

Administrative Skills

Attention to Detail

Job description

Deviation and Compliance Specialist, Swindon

Client: Catalent

Location: Swindon, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: e7b571b57d4c

Job Views: 10

Posted: 26.04.2025

Expiry Date: 10.06.2025

Job Description:

Our Swindon facility houses our Zydis fast dissolving tablet development and manufacturing operation, as well as a CMC pharmaceutical analytical lab services unit that offers ASAP stability.

Catalent is recruiting for a Deviation and Compliance Specialist to join the Operations team. This role involves investigating operational deviations, including laboratory and manufacturing investigations. The specialist will work closely with operations and support functions such as engineering, utilities, and quality. Additionally, the role supports compliance activities including change controls, coaching the operations team, and audit preparation.

Responsibilities:

• Categorize deviations and prepare detailed reports.
• Address QP and customer queries regarding deviations and batch record amendments.
• Assist in audit readiness, including routine Gemba walks and specific audit tasks.
• Identify opportunities for process improvements.
• Ensure adherence to health and safety policies in the workplace.
• Coach and support the operations team on root cause analysis and deviation categorization.
• Manage deviation flow in the manufacturing department to ensure timely QA/QP review.
• Serve as a customer contact for deviation-related questions or concerns, alongside QP/QA associates.
• Provide process expertise to assist with deviations.
• Manage temporary change controls and reprocessing activities, ensuring proper communication and documentation.

Candidate Requirements:

• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Strong administrative skills with keen attention to detail.

Catalent offers rewarding career opportunities! Join a global leader in drug development and delivery, helping bring over 7,000 products to patients worldwide. We are an innovative, expanding company working with pharma, biopharma, and consumer health clients. We produce over 70 billion doses annually, making a real difference in people's lives. Join us to make an impact.

We value personal initiative, work at a dynamic pace, and believe in meaningful work.

Explore career opportunities with us.

Catalent is an Equal Opportunity Employer and does not discriminate based on protected characteristics. If you require reasonable accommodations during the application process due to a disability, please contact us via email with your request, including the job number, title, and location.

Note to agencies and search firms: Catalent does not accept unsolicited resumes from agencies without a signed agreement. Resumes submitted without such an agreement will be the property of Catalent, and no fee will be paid for candidates hired through unsolicited referrals.