We have a fantastic opportunity in Galway with a global Pharmaceutical company for an experienced Quality Assurance Executive(Quality Engineer) to join an established team on a day shift role, Monday-Friday. This role reports to a Quality Team Lead & QP within the group and offers the opportunity to gain expert knowledge in sterile manufacturing, exposure to all quality system aspects in a multi-national organisation and on-going training/ development. Progression opportunities to advance to senior/ team lead position in time will also be available for the successful person if they so wish to develop their career further within the organisation.
• 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.
• Aseptic sterile pharmaceutical manufacturing experience of various forms with experience in a Quality Assurance department role ideally.
• QC experience also considered.
• A minimum of 5-8 years relevant experience.
• Pharmaceutical Quality Assurance Experience
• Experience of all quality system aspects including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, and batch release.
• Good team worker with excellent attention to detail.
• Communication skills, willingness to learn, team player, taking initiative, adaptable, strong written and verbal communication skills. Experience of working with various IT systems and software packages.
• Sterile manufacturing experience.
• Experience with quality management software systems such as Trackwise
If you would like further Information you can contact the recruiter directly:
Karen Shiel | Tel: +353 (0) 1 5079256