Senior QA Associate

Team Horizon is seeking a QA Senior Associate on an initial 12-month contract for our Dublin based client who are a global leader in the field of biotechnology.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• Ensure adherence to safety standards and SOPs in all activities.


• Review and approve production batch records and associated documentation for Qualified Person disposition activities.


• Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.


• Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.


• Offer Quality Assurance support for on-the-floor investigations and deviations.


• Review and approve deviations for closure, ensuring compliance with appropriate documentation.


• Participate in customer complaint investigations.


• Conduct routine Quality Assurance walks on the production floor.


• Review and issue logbooks, ensuring compliance with procedures.


• Provide training and guidance to staff for effective performance.


• Review and approve cGMP records, ensuring compliance with appropriate documentation.


• Support continuous improvement and Operational Excellence initiatives.


• Undertake other tasks/projects as assigned by the manager.


• Role supports 24/7 manufacturing so shift work is required and a shift premium is applicable

What you need to apply:

• University degree in an Engineering or Science-related discipline


• Over 4 years of relevant experience in the pharmaceutical or biotechnology industry or an equivalent combination of experience and educational background.