Quality Validation Technician - Sligo

COLLINS MCNICHOLAS RECRUITMENT

SLIGO

Our client, a leading company in Sligo, is seeking a number of Quality/Validation Technicians on an initial six month contract. Major Duties and Responsibilities. Ensure all aspects of activity within the Quality Engineering Group adhere to required policies and procedures, including safety and training. Ensure that the plant meets the quality requirements of its customers with respect to Validation and Calibration, ISO 9001:2015 / ISO 13485:2016. Be involved in all Validation Cross Functional Teams (CFT’s) at the site to ensure adherence to required policies and procedures, including safety and training. Assist in preparation and execution of validation protocols. Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective. • Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Trials (FAT’s) and any other associated validation issues. Lead validation aspects of Facility, Utility, Equipment qualifications. Conduct Test Method Validation, Gauge R&R. Lead software validation and 21CFR Part 11 assessments. • Assist in the development of the existing Validation Program at AIDD to ensure continued compliance to the necessary regulations. • Collate and Report on relevant Validation data/matrices. • Ensure prompt attention to the Quality Engineering Team/Unit Leader, Quality Engineering Manager and Quality Manager on areas of non-compliance. Ensure all Validation and Calibration documentation meets the requirements of Quality Records Procedures. Keep abreast of developments in customer requirements to ensure the plant continues to produce quality products under regulatory requirements. Participate as required in project activities to achieve plant goals. Ensure all relevant employees are aware of Division and relevant International Standards and their implementation throughout the plant. Participate in identifying and implementing cost reductions, which do not adversely impact product quality. Complete all activities in a safe manner ensuring that any potential safety issues and areas for improvement are highlighted to Manager. Ensure Environmental procedures e.g. recycling, waste minimisation are adhered to and improvements made where possible. Requirements: 2-5 years relevant experience. Third level degree background in a relevant science/engineering/validation field. For a confidential discussion and more information on the role, please contact Colin Byrne. colin.byrne@collinsmcnicholas.ie. (071) 9140255. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.

1417 days ago