Quality Specialist

With nearly 25 years of experience our Bathgate location in Scotland UK is an integral part of Catalents European clinical supply services network. This 141000 sq. ft. facility has a comprehensive range of capabilities to support sponsors studies throughout the UK Europe and beyond including clinical supply management Fast Chain demand-led supply clinical-scale commercial packaging and QP release services.

We have high-speed automated primary packaging for blisters as well as semi-automated primary packaging for bottles. We offer packaging design services on site as well as secondary packaging and clinical labeling services.

We have an opportunity for a Quality Specialist to join our team and support our Quality (GMP) objectives and 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.

Shift: Monday - Friday

Location:

Bathgate UK
100% Onsite

• 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 Track Wise 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.

• 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.

• Be part of a site with nearly 25 years of experience and a key role in Catalents 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 Catalents global network.
• Subscription to Linked In Learning with access to over 10000 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.

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…