Job Description

Key Responsibilities 
• All activities within Company’s Quality System associated with QC Deviations, CAPA records, Analytical Results Assessments and Change Control. 
• 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. 
General Responsibilities: 
• Audit and Inspection preparation and participation. 
• Lead continuous improvement activities to achieve standards of operational excellence for the company. 
• Perform tasks and participate on project teams assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals. 
• Apply expertise and critical thinking to independently resolve issues. 
• Provide technical guidance. 
• Be responsible for specific programs and/or projects. 


Requirements

Key Competencies: 
• Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information. 
• Anticipate and prevent potential problems. 
• Excellent verbal and written communication skills including technical writing, presentation and facilitation skills. 
• Strong ability to lead teams and effectively utilize team resources. 
• Ability to evaluate complex compliance issues. 
• Ability to work in a fast-paced environment with changing priorities. 
• Excellent Organisational Skills and Time Management. 
• Ability to work under minimal supervision. 
• Ability to identify and manage competing priorities. 
• Skills in the areas of teamwork, flexibility, coaching and motivating. 
Knowledge and Experience: 
• Hold a third level qualification in a Science related discipline. 
• Minimum 4 years’ experience in a Biotechnology/ Pharmaceutical/ GMP Environment. 
• Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP. 
• 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.

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