- 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 qualifications and essential functions for this position:
- 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.
- 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
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.