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Senior QC Specialist job in Dublin at Headcount Solutions Limited

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Senior QC Specialist at Headcount Solutions Limited

Senior QC Specialist

Headcount Solutions Limited Dublin, Dublin City, Suffolk Full-Time
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Senior QC Specialist - Investigations

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

For more information contact Nicola on (phone number removed) or email your CV in the strictest confidence to
 

Recommended Skills

Product Quality Assurance
Auditing
Corrective And Preventive Action (Capa)
Good Manufacturing Practices
Lean Manufacturing
Quality Management Systems
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Job ID: 213536178

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