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Details

Senior Associate QC Systems (Investigations & Change Control)


Reference:SMC028794 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst

We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Report writing for investigations.
• Own and manage Change Controls through their life cycle for QC.
• Lead, contribute to, oversee, run and participate in Root Cause Analysis, implementing improvements and Corrective Actions.
• Trend analysis of Deviations relating to QC.
• Ensure investigations constantly reflect current requirements and expectations.
• Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings.
• Ensure timely completion of QC Deviations, CAPAs and Change Controls utilizing the appropriate procedures and Quality Management Tracking System (QMTS).
• Ensure timely completion of each stage of the Analytical Results Assessments in line with the Quality Control Out of Specification and Unexpected Results procedure(s).
• Ensure flow of communication to stakeholders.
• Develop and maintain quality systems within QC to ensure ongoing compliance with cGLP.

Knowledge and Experience

• Hold a third level qualification in a Science related discipline.
• Experience in a Biotechnology/ Pharmaceutical/ GMP Environment.
• Experience with Deviations and Laboratory investigations including CAPA identification and implementation.
• Experience in leading Root Cause Analysis would be advantageous.
• Experience in managing and owning Change Controls would be advantageous


If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480