Upto 100k €
8 months ago
QA Operations Manager
A fast-growing pharmaceutical company based in Cork; Ireland is looking for a QA Operations Manager to join their high performing quality team. This company is a very established with major growth and conducts ground-breaking science on a global scale every day.
The position you will lead, develop and co-ordinate the activities of the QA Operations Team. You will manage the activities of the QP and act as a Qualified Person for the site when required.
Key responsibilities include but are not limited to the following:
Ensure that internal and external standard is met to (cGMP Regulatory requirements) for commercial products.
Manage the QA operations team
Support inspections and audits from external parties (e.g. FDA, IMB, EMEA or alliance partners).
Oversee key quality systems such as (CAPA /ER report system, Change Review Board system etc..)
Completing the Annual Appraisals of QA operations staff and ensuring stretch goals, and appropriate learning and development goals for each
Preparation and Approval of the Annual Product Review
Participate in technical and scientific meetings, in training days, trade fairs, conferences
3rd level qualification
Currently enrolled or completed education to meet the requirements of QP
Previous Managerial/ Supervisory experience is essential
Demonstrated ability in Leadership, Management, and development of a team in the pharmaceutical area
Experience of GMP auditing and documentation
Excellent communication skills and presentation
If this role could be of interest or any questions, don’t hesitate to get in touch!