Quality Assurance Senior Specialist

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dundalk. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This role is responsible for oversight of all validation activities ensuring compliance with current regulatory requirements, cGMP and company SOPs. It includes validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, controlled temperature units (CTUs) and shipping. An important aspect of this role is provision of QA oversight to the Commissioning, Qualification and Validation (CQV) activities associated with the facility’s start-up project and supporting the transition from project phase through to sustaining phase with respect to validation activities.

Duties: