Our client, a pharmaceutical company in Galway are currently looking to recruit a Quality Assurance Executive Level III for their site.
About the role:
- Manage the company’s Permanent and Temporary Change 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’s GMP 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.
- Minimum of a Bachelor's degree (or equivalent) in a Science related discipline
- 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.
- 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.
- 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.)
- Proficiency in speaking, comprehending, reading, and writing English is required.
For further information on this in Quality Assurance Executive Level III please contact Clara Burke on 086 8168273 / email@example.com
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