Support Quality Management, and 17025 ISO certification for Fannin LIP Galway through activities such as:
Perform tests and reporting of results as per product specificationsSupport, develop and implement QC procedure, processes and systemsAssist with the development of in-house documents e.g. Standard Operating Procedures, Validation Protocols, Risk Assessments, technical files etc.Adhere to QC documentation systemPerform weekly testing of R.O. water used for manufacturingEnsure culture maintenance – organisms from LGC – ATCC and Public Health England – NCTCCarry out environmental monitoring for specified manufacturing areas and the QC laboratoryPerform competency and EQA testing as requiredProvide Microbiological support to the sitePerform or support equipment calibration and verificationSupport issues management (Non-Conformances, Complaints, Vigilance, and Recalls or FSCA)Participate in and responsible for QC related CAPA'sPrepare for and support accreditation, regulatory and customer inspections and auditsSupport projects and continuous improvement initiatives within the Quality department and other department areasAdhere to safety requirements to ensure a safe working environment for all team membersAdhere to accreditation requirements under ISO17025 and ISO9001Qualifications & Experience: Relevant third level qualificationKnowledge and proficiency in an array of microbiological techniquesKnowledge of ISO standards associated with laboratory activitiesExperience in ISO 17025, ISO 15189, ISO/TR 22869Experience in Antimicrobial susceptibility testingTest method validation, process validation and Risk management experienceEnvironmental monitoring experiencePersonal Characteristics and Experience Profile Required: The principal skills, experience and personal characteristics, which the successful candidate will be able to demonstrate are:
Pro-activeComfortable in a fast-paced working environment and able to adjust workload based upon changing prioritiesAbility to think critically and demonstrate troubleshooting and problem-solving skillsStrong oral and written communication skillsStrong interpersonal skillsAbility to plan and prioritize work to meet commitments aligned with organizational goals
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