This leading global speciality pharmaceutical company are focused on providing therapies to unmet patient needs. They are a market leader in development, with a diverse portfolio across branded products and generics, as well as API products.

They are seeking an experienced QA Specialist to support the operation of their core quality systems at their state-of-the-art manufacturing facility in North Dublin on a contract basis.

The Role

Duties and responsibilities of the QA Specialist will include:

• Oversee investigations, OOS and unplanned events workflows to ensure they are performed correctly, assist in Root Cause Analysis investigations as required
• Oversee change control management process ensuring impact of proposed changes are adequately assessed how the implementation is managed
• Assist with compilation and analysis of data associated with performance of the Quality System (e.g. Management Reviews)
• Responsible for the management of GMP training and to foster a quality led culture across the new site
• To conduct supplier audits, Internal audits and co-ordinate regulatory audits
• Assist with preparation and execution of back room activities for Health Authority Inspections
• Perform batch review and approval of release documentation

The Person

You will have skills and experience in the following:

• BSc in a scientific discipline
• 4+ years relevant industry experience in Quality Assurance
• Experience working with Quality Systems such as Deviations, Change Controls, Training, Supplier Qualification and Document Management systems
• Must be able to function effectively in a teamwork environment
• The individual must demonstrate an ability to work independently
• Thorough, diligent, good attention to detail

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.