Senior Quality Specialist

Eurofins BPT are actively seeking a Senior Quality Specialist to join our Quality team in  Dungarvan, Co Waterford.

The purpose of this job is to support the implementation and development of the Quality System in the company.

• Continuous improvement of Quality Management System, including but not limited to internal audits, supplier management, change control, exception systems.
• Prepare agenda for weekly Quality Meetings, to include metrics on number of documents pending review etc.
• Deputise for the Quality Manager, as requested in terms of review and approval of documentation and supervision of staff as necessary
• Responsible for ensuring all internal and supplier audits are completed as scheduled
• Management of Controlled Drugs
• Operation and maintenance of the Exceptions system.
• Co-ordinating the resolution of issues surrounding non-conforming work as necessary with Laboratory Management.
• Completion of internal audits.
• Operation and maintenance of the Audits module within LIMS.
• Support the co-ordination and compilation of client audit and regulatory inspection responses.
• Support the co-ordination and compilation of information for regulatory bodies as requested.
• Support the hosting of client audits and regulatory inspections – point of audit set up, Quality Department representative during audits.
• Proposing and implementing improvements to the quality system in line with industry best practices and standards.
• General upkeep of the quality system through a plan of continuous improvement from CAPAs, audits, review of procedures and regulatory/legislation updates.
• Review and Co-ordination of technical and quality agreements.
• Co-ordinating and submitting information to clients as requested – questionnaires, requests for regulatory information.
• Operation of the Supplier Approval system.
• Administration and control of external documentation including client methods and SMIS.
• Delivery of quality systems training as required.
• Assist in the preparation and delivery of the Annual Management Review process.
• QA approval of procedures and protocols.
• QA approval of certificates of analysis and technical reports.
• QA approval of Exceptions.
• Controlled Drugs :
• • Responsible for the activities related controlled drugs system across site 
• • Obtaining / maintaining licences for possession or import or export of controlled drugs as necessary
• • Point of contact for the HPRA in relation to the activities involving controlled drugs management on site which includes but not limited to reconciliation, stock returns, maintenance of licences, adherence to procedures and compliance to the legislations.