Senior QC Specialist – Investigations – REF NHA40

Overview:
A career advancing opportunity has arisen for a Senior QC Specialist within a Dublin based biopharmaceutical multinational. The successful candidate will join the investigations team as a senior member of the team. Continuous Improvement with regard to investigations and error management will be key areas of focus for the role.

 

Key Responsibilities
• Champion for Investigations in Quality Control
• Owns and Manages Investigations for QC through QMTS
• Authors and reviews investigation reports
• Participates routinely in the investigation triage process
• Ensures investigations are kept up to date and compliant with procedures
• Ensure investigations result in robust CAPA to prevent recurrence
• Seeks out opportunity to improve the process and management of Investigations
• SME for error management and error reduction in QC
• Lead improvement initiatives as required
• Strong focus on RFT and Lean
• Key contact for Investigation Metrics
• Responsible for on time co-ordination of QC Investigation Trend reports
• May own Change Controls linked to investigations and CAPAs
• Supports Audits and Inspections with regard to preparation and participation
• Represents QC at site and network level with regard to Investigations and Error Management.

 

Knowledge and Experience:
• Hold a third level qualification in Science related discipline
• Have minimum 6 years’ experience in Biotechnology/ Pharmaceutical setting
• Possess key competencies to include Planning and Organisation, Communication, Teamwork, Flexibility
• Excellent Technical Writing skills
• Proficient in Root Cause Analysis
• Detailed knowledge of the QC function and is operationally savvy
• Proven Experience of handling GMP investigations within a Quality System
• Demonstrated Leadership attributes: Delivers Results
• Knowledge of Error Management Methodologies and experience with Six Boxes Approach advantageous

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