QA Analyst

Pe Global

Cork

PE Global are currently recruiting for QA Analyst for a client in Cork. Responsibilities of the role: Provide quality oversight/input on the production floor to ensure process quality requirements such as data integrity, product segregation, etc. are adhered to. Represent quality for process improvements. Support process investigations providing formal structured approach to identify root causes, established corrective actions and execute prevention plans in products and/or processes. Provide quality oversight/input on the project to ensure Quality requirements such as data integrity, product segregation, etc. are adhered to. Support investigations related to the project providing formal structured approach to identify root causes, establish corrective actions and execute prevention plans in products and/or processes. Complete and provide guidance on validation activities within the assigned project. Support the execution of validations/commissioning within assigned area. Support assigned risk managements to prevent unanticipated failure modes and improve capability of processes. Ensure continual Quality System compliance by adherence to established and evolving, regulatory requirements. Adhere to in-house H&S and environmental requirements when supporting the introduction of new equipment, products or processes. Support preparation and actively participate in internal audits and external audits by Notified Bodies and Health Authorities, where necessary. Education and experience required: Bachelor’s degree in a technical discipline. 2 years process quality engineering experience with technical & validation experience. Knowledge of FDA, medical device, GMP and validation requirements. If you are interested in this position, please forward your CV to catherine.osullivan@peglobal.net or call Catherine on 0214297900. This job originally appeared on RecruitIreland.com.

2318 days ago