- 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: email@example.com
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