• 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.
• 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.
• 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.