QC Systems Senior Associate Change Control

at  ORION

Job description

QUALIFICATIONS & 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, commercialisation, and cGMP.
• Experience using Trackwise/Quality Management Tracking System (QMTS).
• Experience in managing and owning Change Controls would be advantageous.
• 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 organizational 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.
  Our role in supporting diversity and inclusion
  As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment

• Own and manage Change Controls through their life cycle for QC.
• Ensure timely completion of QC Change Controls utilizing the appropriate procedures and Quality Management Tracking System (QMTS).
• Ensure flow of communication to stakeholders.
• Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information.
• Monthly Metrics Management and Reporting.
• Participate in cross functional change controls.
• Contribute to success of QC Goals.
• Audit and Inspection preparation and participation.
• Lead continuous improvement activities to achieve standards of operational excellence/
• 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.