Quality Manager - QP
Fantastic opportunity for an experienced QA leader to join a Pharma multinational in the Waterford Region.
To manage and lead the Quality assurance processes to ensure all relevant activities (e.g. Batch review, Qualified Person release and Operational GMP compliance) comply with all GMP and Regulatory requirements.
Lead, motivate and develop a team of 20+ across the QA function
Create an atmosphere of respect and trust, in which concerns can be fully raised.
Lead the Operational Quality function in preparation for, and during external agency audits and internal audits
Review of batch documentation, test results and all other documentation associated with certification (for EU) and release of Finished Product
Assessment of Deviation investigations associated CAPA effectiveness and trending of deviations.
Product certification (for EU) and release
Shift-based oversight of facilities, equipment and personnel to ensure real-time compliance to procedures, instructions, contemporaneous data integrity and other cGMP requirements. Including participation in Rapid Response approach to address deviations, with Operations, Engineering and Technical.
Site Qualified Person responsible for the release of medicinal product to markets
Be a role model for effective Escalation, Ownership and Decisions.
Deliver excellence through you and your team being the best you can be.
Empower, Coach and Support all colleagues.
Permit and promote only desirable activities and behaviours.
Science or related Degree
Strong proven leaderships skills in a similar QA role in a pharma environment
QP Certified preferable
For a confidential discussion and more information on the role, please contact Rory Walsh.