Through expansion of operations my client based here in Co Galway - Inverin, is looking for a Quality Lead to join their team.
The Site Quality Council Lead is responsible for reporting of site quality metrics to Global Quality Leadership and ensuring that Global Quality policies are understood and implemented. You will be responsible for the maintenance of Global Quality programs such as the Quality Action System and for the management of site external communications in the handling of customer complaints, the filing of field alerts and audit management (preparation and communication).
The role requires an active partnership with the Senior QA Manager & Site Qualified Person in transforming the site quality system to support the site to ensure that global quality policies are implemented and that high standards of GMP are maintained at all times.
- Manage the day to day administration of the assigned Quality Management System elements in line with GMP and appropriate global and site policies and procedures.
- Provide direct leadership and guidance to all assigned Quality Assurance staff to enable excellent performance while maintaining a positive team environment.
- Develop and implement effective performance monitoring indicators for direct reports.
- Provide QA input into relevant Risk Management programs within the company.
- Demonstrate commitment to high standards of GMP compliance and product quality.
- Foster a good working relationship within the QA department and with all other departments.
- Interface with site operation owners to collect and analyse key data related to Quality Metrics.
- Establish and provide consistent timely analysis and publication of key quality metrics.
- Assist in the preparation and management of health authority, corporate or customer audits of the site.
- Assist in providing inspection updates for active Health Authority or Corporate Site Inspections to Site Management Team and Global Quality Compliance team.
- Deputise for the Senior Director Of Quality or Senior Quality Assurance Manager as required.
- Minimum of a Bachelor's degree (or equivalent) and 5+ years of experience. However, a combination of experience and/or education will be taken into consideration.
- Must possess knowledge of Pharmaceutical Quality Systems.
- Knowledge of working within an FDA/HPRA regulated facility.
- Must possess the ability to understand technical documents and can communicate description of problems and solutions.
- Excellent attention to detail.
- Strong interpersonal and organizational skills.
- Computer skills including Word, Excel and MS Outlook.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney firstname.lastname@example.org, 091 706 717.