Quality Validation Engineer - Sligo
Harry Walsh Associates Ltd
Sligo
Opportunity to join an expanding bio facility as a quality validation engineer. 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 Quality System Documentation is thorough, complete and complia. 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 year 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. This job originally appeared on RecruitIreland.com.
2270 days ago