QA Specialist

Catalent are currently recruiting for a Quality Specialist II to join the Bathgate site. The Quality Specialist will carry out functions relevant to the Quality (GMP) objectives and policies of Catalent Limited.

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.

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.

The Candidate:

• 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.

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 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 [email protected]. 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.