Quality Assurance Executive

Brightwater

Tipperary

An exciting Pharma site in Clonmel has a requirement to add to its existing Quality Assurance team. If you want the opportunity to work in a demanding and fast paced start up environment then this role will give you excellent exposure to all aspects of FDA regulated Quality Assurance for production and Technical Transfers. About the Job: Support 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. Support the internal audit program. Support Customer Quality Complaints/Medical Device Vigilance systems. Supportthe company’s GMP training program. Supportthe company’s routine commercial stability program. Supportmonthly/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. About You: Minimum of a Degree in Chemistry, Science or equivalent. Minimum of 2-3 years of relevant experience. 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. Ability to handle multiple tasks in a fast-paced environment with strong organisational and time management skills. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

1856 days ago