Deviation and Compliance Specialist
Deviation and Compliance Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) committed to helping people live better healthier lives. We partner with pharmaceutical biotech and consumer health companies to support product development launch and full life-cycle supply. With over 40 global sites and thousands of scientists and technicians Catalent delivers billions of doses of life-enhancing and life-saving treatments annually.
Were currently seeking a Deviation and Compliance Specialist to join our dedicated team within the Production department. This team supports operations across all aspects of deviation handling and compliance ensuring smooth and efficient batch progression.
The Role:
- Drive timely closure of Deviation records including manufacturing investigations and customer complaints.
- Mentor Operations colleagues in root cause analysis (RCA) and deviation reporting.
- Generate and communicate daily deviation reports to Operations via the Trackwise workflow.
- Manage the flow of Deviation records through Zydis manufacturing supporting batch progression to QA/QP review in line with tracker timelines.
- Act as the primary contact for all Deviation activities ensuring thorough resolution through corrective and preventative measures.
- Collaborate with QA/QP personnel to respond to customer concerns related to deviations.
- Offer expert process insight to assist with data gathering for RCAs and Tripartite reviews.
- Proactively spot and support opportunities for process improvement.
The Candidate:
- Experience in report writing (advantageous).
- Prior exposure to contract manufacturing (advantageous).
- Strong communication skills in both written and spoken English.
- A diplomatic multitasking mindset with confidence in cross-functional collaboration.
- Solid organizational skills and the ability to meet tight deadlines.
- Advanced proficiency in Microsoft Office Suite (Word Excel PowerPoint Access).
- Comfortable working in a fast-paced production floor environment (PPE provided).
Why You Should Join Catalent:
- Competitive Salary Reflecting your experience and skills.
- Bonus & Benefits Includes an annual performance bonus a pension scheme matching up to 8% and life assurance. Enjoy BUPA private medical insurance a generous holiday entitlement that increases with tenure and the option to purchase additional leave. Plus gain access to Reward Gateway offering discounts at many national retailers.
- Career Development Access high-quality training mentoring and cross-functional opportunities within Catalents global network. Benefit from a subscription to LinkedIn Learning providing access to 10000 online courses.
- Health & Wellbeing Includes an employee assistance programme on-site canteen facilities and an active safety and Patient First culture. Take advantage of a Cycle to Work Scheme and an Electric Vehicle car scheme. Join Employee Resource Groups that foster a diverse and inclusive workplace. Plus participate in charitable activities.
- Excellent Location Just a two-minute drive from J16 of the M4 with free on-site parking
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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 Catalent Careers 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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
