Quality Specialist

With nearly 25 years of experience, our Bathgate location in Scotland, UK is an integral part of Catalent's European clinical supply services network. This 141,000 sq. ft. facility has a comprehensive range of capabilities to support sponsors' studies throughout the UK, Europe and beyond, including clinical supply management, FastChain® demand-led supply, clinical-scale commercial packaging, and QP release services., We have an opportunity for a Quality Specialist to join our team and support our Quality (GMP) objectives and policies. In this role, you will provide Quality Assurance expertise to ensure processes meet the highest standards. You will manage GMP documentation, review material specifications, and ensure compliance with pharmacopoeia, GMP, and client requirements. This position offers the chance to work closely with cross-functional teams and contribute to continuous improvement initiatives.,

• Carry out functions relevant to the Quality (Good Manufacturing Practice) objectives and policies of Catalent Limited.
• Provide Quality Assurance expertise to ensure Quality processes operate to acceptable standards.
• Manage the control, tracking, and timely flow of Good Manufacturing Practice documentation to support production schedules.
• Review and approve material specifications, ensuring compliance with pharmacopoeia, Good Manufacturing Practice, and client requirements.
• Review and approve incoming, intermediate, and finished materials for release.
• Review and approve randomisations, Good Manufacturing Practice documentation, and packaging batch records for accuracy and compliance.
• Liaise with cross-functional teams to resolve quality issues and maintain delivery timelines.
• Support Quality Management System activities, including timely closure of TrackWise records.
• Conduct internal audits, monitor trends, and support continuous improvement initiatives.
• Host client audits and coordinate responses to audit observations and corrective actions.
  
  Bachelor of Science in a relevant scientific topic or appropriate Quality experience in a pharmaceutical environment.
• Proven number of Quality experience in a Pharmaceutical or Clinical Trials setting.
Preferred Skills & Background
• Excellent verbal and written communication skills.
• High level of concentration and attention to detail.
• Ability to prioritise daily and weekly workload.
• Ability to work independently.
• Strong analytical and problem-solving skills.
• Ability to be decisive on material and product quality issues to ensure compliance.
• Knowledge and experience in environmental monitoring is desirable.
• Comfortable in a client-facing setting.
  
  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.
  
  Be part of a site with nearly 25 years of experience and a key role in Catalent's European clinical supply services network.
• Competitive salary reflecting your experience and skills.
• Pension scheme matching up to 7.5% and life assurance.
• BUPA private medical insurance and generous holiday entitlement that increases with tenure, plus the option to trade leave.
• Access to high-quality training, mentoring, and cross-functional opportunities within Catalent's global network.
• Subscription to LinkedIn Learning with access to over 10,000 online courses.
• Employee assistance programme, on-site canteen facilities, and a strong "Patient First" culture.
• Join Employee Resource Groups that foster a diverse and inclusive workplace and participate in charitable activities.
• Excellent location near J3A of the M8 with free on-site parking.