QUALITY ASSURANCE EXECUTIVE III
Q.A. Team Leader
Inverin,Co. Galway Ireland
The Quality Assurance Executive will be responsible for assisting with the management of specific elements of the Quality Management System. These elements include the site change control procedure, deviation handling procedure, customer complaints and incoming inspection
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Manage the company’sPermanent and TemporaryChange Management system.
- Maintenance of the incident report system (unplanned deviations), supplier non-conformance system and the CAPA system.
- Manage the internal audit program.
- Manage Customer Quality Complaints/Medical Device Vigilance systems.
- Manage the company’sGMP training program.
- Manage the company’s routine commercial stability program.
- Prepare monthly/quarterly/annual KPI/Management review data and annual product quality review reports.
- Perform detailed batch record review of finished products prior to QP/QA release.
- Deputise for the QA Team Leader if required.
- Perform other duties as assigned.
Experience of all quality system aspects including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, and batch release.
Experience of TrackWise or similar electronic document management systems is highly desirable.
SKILLS AND ABILITIES
Excellent communication (oral & written) and presentation skills.
Ability to handle multiple tasks in a fast paced environment with strong organisational and time management skills.
Experience of working with various IT systems and software packages with strong working knowledge of Microsoft Office (Word, Excel, Powerpoint etc.)
Minimum of a Bachelor's degree (or equivalent) in a Science related discipline and 5-8 years relevant experience within a pharmaceutical company with a minimum of 2 years’ experience within a Quality Assurance role.
Experience of sterile manufacturing desirable but not essential.
However, a combination of experience and/or education will be taken into consideration
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments. Ability to write and speak with fluent English essential.