Senior Validation Engineer- Sligo

Collins Mcnicholas Recruitment

Sligo

Senior Validation Engineer- Sligo Senior Validation Engineer required in Sligo within the Medical Device Manufacturing sector. Excellent future prospects with this role. Experienced individual required, process & equipment validation with CSV experinece a distinct advantage. Key Responsibilities. Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements. Coordination and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards. Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements. Audit the quality system with other personnel where required. Assist in the investigation and coordination of customer complaints and assess need for implementation of effective corrective or preventive actions. Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, and verification of corrective and preventative actions. Measure performance of the Quality System and providing metrics, for inclusion in the management review, monthly reports etc. Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training. Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary. Ensure implementation and compliance with relevant Regulatory requirements.Ensure Quality System Documentation is thorough, complete and compliant. Ensure compliance to training is maintained. Review Lot Records, ensuring documentation is compliant to requirements and complete lot release for shipment. Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site. Requirements : 3 year plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment. Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as; process validation, design controls, CAPA, auditing, etc., is desirable. Experience in an injection moulding or tooling environment is desirable. Experience in Computerised Systems Validation is desirable. More detailed job spec available upon request. *********************************************************************************************************** For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or emaildavin.ferguson@collinsmcnicholas.ie. 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 www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos! This job originally appeared on RecruitIreland.com.

2298 days ago