Catalent are currently recruiting for a Quality Specialist to join the Bathgate site. The Quality Specialist will carry out functions relevant to the Quality (GMP) objectives and policies of Catalent.
This role will see you join the dedicated and Quality function that are an integral part of our success here at Catalent. In this role you will be responsible for the movement, control and tracking of documentation to adhere to the production schedule.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
Working hours; Early shift 7am - 3pm Late - 2pm - 10pm - alternating
The Role:
To be responsible for the movement, control and tracking of documentation, ensuring a timely flow to adhere to the production schedule.
Review and approve Material Specifications to ensure compliance with pharmacopoeia and client requirements.
To review and approve Incoming Bulk, Intermediate and Finished Materials to ensure compliance with pharmacopoeia and client requirements
Review and approve Randomisations to ensure compliance with GMP and client requirements
Review and approve GMP information to ensure accuracy and compliance with company procedures.
Review and approve production (Pre and Post Packaging Batch) Records to ensure compliance with GMP and company procedures.
Liaise with relevant department staff and management on quality issues and timelines.
Review and approve observation and deviation reports to ensure compliance with GMP.
Perform internal audits as scheduled and monitor / trend findings. Walkthroughs.

Educated to HNC level in relevant scientific topic or equivalent in a pharmaceutical environment.
Experience of Pharmaceutical/Clinical Trials Packaging and GMP Processes
Excellent verbal/written communication skills.
A high level of concentration and a good eye for detail is essential.
The ability to be decisive when required on material/product quality issues to ensure compliance.

Annual Salary
Pension
Life Assurance
Bupa Healthcare
Opportunities to join Employee Resource groups and be involved in charity events
We have been made aware of potential inaccurate job advertisements on third-party websites. Please consider Catalent's Career Site as the trusted and accurate source of information for any jobs available with Catalent.
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.