Quality Assurance Specialist

Client: Pharma
Type: Contract
Location: County Carlow
Duration: 10 months

Responsibilities

• 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

Qualifications

• 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 / ukaldi@planet-pharma.co.uk for more information