Quality Assurance Specialist
- Experience Level
- Experienced (non-manager)
Location: County Carlow
Duration: 10 months
- Actively participate in Plant/Quality committees and works with other site functional groups, such as the EC Laboratory, Production, Utilities, Site Services, and Maintenance
- Aid the effective implementation of the Quality Management System, and facilitate the continuous improvement of same ensuring the Quality Management Systems
- Support the introduction of new products to site in relation to Quality oversight.
- Partner with colleagues cross-functionally to provide support and advice on a day to day basis and on a project basis, including communications, training, project work, audit/inspection duties, investigations, batch work, customer queries, etc.; thereby ensuring department is audit/inspection ready.
- Conduct self-inspections and external audits as appropriate.
- Initiate and maintain Quality related metrics, ensuring effective communication and follow up (Monitoring of quality systems, self-inspection program, Verification of the effective implementation of key GMP programs, Effectiveness of Preventative Actions Review, Verify site documentation)
- Review of site documentation for regulatory impact (e.g. Product Specification Files, QC documents, EBR updates, Quality Notifications, Stability protocols and reports, Validation protocols and reports, process description).
- Periodic auditing of CMC portion of filings against site systems to ensure continued filing compliance.
- Management of Change Controls (Including Global changes, ORB prioritization, VCMT, PSQTS, etc.) and Tracking regulatory approvals.
- Management of queries from CMC, Health authorities, downstream sites including final releasing QPs relating to registered products and products for registration.
- Provide training in all aspects of Quality Management Systems and GMP.
- Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
- Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.;
- Oversee and implement subsequent corrective action through the change management system. Drive compliance with companys Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practice
- Bachelors Degree in a related Science discipline, Engineering or other Technical Discipline.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Extensive knowledge of the following Change Control, Deviation Management and Self-Inspections
- Knowledge of GMP and GDP required
- Lean Six Sigma Methodology experience desired
Please contact Urszula Kaldi on +44 (0) 203 868 1009 / firstname.lastname@example.org for more information
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