Quality Assurance Specialist

Location
Carlow (County), Leinster (IE)
Salary
Competitive rates
Posted
03 Jul 2019
Closes
02 Aug 2019
Ref
UK_ 100144_IRE
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

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