Quality Validation Engineer

Sigmar Recruitment

Sligo

Key Responsibilities Include: 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, 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 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. Education & Experience: Degree in Engineering or Science or relevant technical degree. Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable. 3 years plus experience in the day-to-day operation of the quality system in a highly regulated product/device or pharmaceutical manufacturing environment. Minimum 3 years working knowledge of quality systems medical device/pharmaceutical regulations 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. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: jporter@sigmar.ie. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. This job originally appeared on RecruitIreland.com.

2230 days ago