Reporting to the Quality Director this is a 12 month contract for immediate start. There are excellent opportunities that additional (contract / perm) assignments will present themselves following the initial 12 month period.
This role will have responsibility for the management and maintenance of the Quality Management Systems (QMS) related to the business activity.
The key responsibilities assigned to the Quality Assurance Specialist relate to the management, development and administration of the QMS and operational procedures which include the following :
• Management, maintenance and development of service delivery, meeting or exceeding customer expectation(s), within the requirement of Good Manufacturing Practice (cGMP) and Good Distribution Practice (cGDP).
• Participation in service development initiatives.
• System owner for process’ as defined by QA Director.
• Point of Contact for Affiliates as defined by QA Director for QA related activities
• Management of QA activities of assigned portfolio of contract manufacturing organization(s) and other related activities.
• Maintenance of quality documents.
• Management, storage and control of quality records. Administration and management of any updates to quality related documents e.g. SOPs, QTAs, Vendor files, Change Controls, Deviations etc.
• Control of quality documents in terms of drafting, issue and withdrawal of quality documents.
• Maintenance of the indices of quality documents.
• Maintenance and development of the QMS.
• Implementation of change control in relation to changes made to quality documents.
• Communication of the status of quality documents to all
• Maintenance of templates for quality documents and Quality/Technical Agreements.
• Preparing reports of performance against measures in relating to the Quality Objectives for review at the monthly Operations meeting.
• Ensuring all information is gathered for review and compilation and preparing trend data, as relevant, for review at annual Quality Management review meetings.
• Tracking of registers for changes, deviations, SOPs, internal audits, third party audits, executed QTAs etc.
• Maintenance of all training files for personnel involved in GDP and GMP activities.
• Ensuring regular meetings are organised and minutes taken e.g. Management review, review board for changes and deviations, regular meetings with third parties and affiliates.
• Administrative communications with HPRA, CMOs and affiliates.
• Ensuring Scheduling of audits is drafted and approved and monitoring compliance to schedules.
• Escalation of issues related to QA Director as appropriate, and to advise Quality System Co-ordinator(s) for quality related activities.
• Degree or higher in relevant scientific area
• 2-5 years of QA experience in Pharma, Biotech or Medical Devices.
Contact Brian Christensen on 01 6854747 or submit your CV to email@example.com for immediate consideration
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747