Quality Assurance Engineer

Brightwater

Galway

Are you an experienced Quality Assurance professional ? This is an opportunity to join an expanding Life Science facility in Galway working on an attractive day shift. It`s a permanent role with a competitive salary and benefits package. Ideally you will have at least 5 years of quality assurance experience in a relevant sector, i.e. Pharma or Medical Device, and experience of dealing with external vendors and manufacturers. About the Job: Review batch documentation from Mylan Affiliates and TPM’s for shipment and distribution to the US market, including deviation/ OOS/ incident reports. Investigation and review of product complaints and escalations, Stability OOS and non-conformances of Injectable products manufactured and or released. Ensure CAPA’s are closed in a timely manner. Responsible for New Vendor/TPM assessment, approval and maintenance including generation of Technical Agreements. Prepare and review Change Control/Deviation. About You: Minimum of a Bachelor`s degree (or equivalent) in a life science or pharmacy and 5-8 years of experience in quality control or quality assurance within a pharmaceutical company. Experience of sterile injectable manufacturing and supplier quality management desirable but not essential. Knowledge of Pharmaceutical QMS Systems. Knowledge of Quality Risk Management Systems. Knowledge of cGMPS i.e., USFDA, 2003/94/EC, MHRA and WHO. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

1896 days ago