Regulatory / Quality Coordinator (Co Clare) Key 2 Recruitment has been retained by an expanding medical device /pharma company based in Co Clare to recruit a Regulatory / Quality Coordinator. Choice of hours of work: 7am to 4pm Monday to Thursday and Friday 7am to 1pm. Or 8.30am to 5pm Monday to Friday Duties: Monitor supplier GMP / GDP licenses Source replacements as required. Maintain the QMS documents (Document Review, Document Control). Maintain Customer / Supplier Technical Quality Agreements (TQAs). Monitor / Support customer complaints. Perform the release of diagnostic products to shipping. Perform Start-of-Batch checks and in process inspections. Perform Incoming Inspection including physical verification of packaging materials to ensure they meet quality standards. Perform Documentation initiation request / document change request review. Follow up the execution of Line Clearances. Archive of batch records and retain samples Generate reports such as weekly inspection reports, quarterly reports, trend analysis etc. and assist in any other data compilation as requested by the Quality Manager. Liaise with suppliers and customers on quality related activities. Liaise with corporate on group quality projects. Aid in departmental and regulatory audits (NSAI & HPRA). Manage or support audit response / actions. Aid in maintaining the Complaint Management System, investigations, communications Qualifications: Diploma in Quality Assurance is preferable but not essential, Knowledge of quality assurance activities and experience working with a quality management system is sufficient. For more information on thisQuality Coordinatorposition please contact Key 2 Recruitment, email or call. Skills: Pharma Healthcare Manufacturing Regulatory Benefits: Healthcare Pension