Job Opportunity:
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We are seeking a seasoned Quality Control professional to lead our quality team in Galway. As a key member of our organization, you will be responsible for maintaining accreditation under ISO 17025 and ensuring that all testing is carried out in a timely fashion.
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Responsibilities:
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* Oversee the implementation and maintenance of Quality Management Systems and Standard Operating Procedures (SOPs) to ensure compliance with ISO 17025 requirements.
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* Manage laboratory work planning to ensure timely testing of samples.
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* Schedule, coordinate, and supervise all testing within the QC laboratory to meet company objectives and relevant Key Performance Indicators (KPIs).
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* Supervise and develop the core QC Lab team by mentoring, training, and supporting personnel development plans.
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* Represent the QC laboratory in regulatory and customer audits and coordinate the timely close-out of non-conformance actions/recommendations identified from relevant audits.
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* Develop, maintain, and implement in-house documents, including SOPs, validation protocols, risk assessments, and technical files.
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* Maintain Good Laboratory Practice (GLP) compliance in the QC laboratory.
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* Oversee updates, change controls, deviations, CAPAs, and laboratory investigations related to QC SOPs.
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* Review and apply relevant standards relating to product testing and laboratory compliance.
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* Perform product/batch release following review and verification of test results to ensure product/batch compliance.
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* Ensure publication of batch certificates of analysis on the website when testing is complete, and results confirmed compliant.
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* Coordinate and supervise laboratory investigations to ensure they are captured, documented, and actioned upon within a timely manner.
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* Implement corrective and preventative actions as deemed necessary following Quality team review.
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* Analyze lab-generated data to ensure continual improvement.
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* Support the Quality Department with preparation for Laboratory Management Review and Quality Control meetings.
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* MEDIATE between testing personnel and other departments.
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* Lead internal audits, regulatory audits, supplier audits, and customer audits.
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* Support management and completion of site audit schedule.
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* Lead communication with customers regarding technical queries.
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* Support raw material and supplier performance reviews.
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* Coordinate equipment calibration, maintenance, and qualification according to the predetermined schedule.
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* Maintain lab consumables to ensure continuous supply and no impact on testing.
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* Evaluate and maintain competency and EQA testing-pH and WASP.
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* Arrange and support training, continual improvement, and supervision of test personnel.
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* Provide technical support to QA and Production functions and customers when requested.
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* Advise, facilitate, and implement systems to ensure continuous improvement of processes and services.
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* Ensure test method and equipment validations are completed on time.
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Requirements:
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* Bachelor's/Master's degree in Engineering or Science.
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* 5-8 years of experience in regulated manufacturing - Medical Device, Pharma, Biotechnology, Life Science.
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* 5-8 years of experience in a QC laboratory environment.
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* 2-5 years of management/supervisor experience.
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* Working knowledge of ISO 17025 and IVDD 98/79/EC and/or IVDR (EU) 2017/746.
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What We Offer:
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We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.