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Quality Specialist III

3 months ago


Bathgate, United Kingdom Catalent Full time

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.

Catalent is currently recruiting for a Quality Specialist III to join our Bathgate site. The Quality specialist will work as part of the Quality team and will carry out functions relevant to GMP objectives and policies of Catalent Pharma solutions.

The Role:

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. 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 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. Provide support to the Operations and Quality teams with the investigation and approval of Deviations and Complaints. Provide support to Operations and Quality teams by generating metrics and trending of quality issues, as required. Ensure Management and Qualified Persons are informed of issues which could have an effect on company business or compliance. Work with business areas and participate in continuous quality improvement initiatives and process improvement activities. Attendance at client audits and regulatory inspections, as required. Conduct and report audits as defined by the Internal Audit Schedule, as required. Aid the External Audit Function with respect to follow up/support activities as required.

The Candidate:

Educated to BSC level in relevant scientific topic or equivalent in a pharmaceutical environment or equivalent experience 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 prioritise daily/weekly workload. Ability to work independently The ability to be decisive when required on material/product quality issues to ensure compliance. Quality Management software experience desirable

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. 

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

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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.