Quality Assurance Specialist
Current- Responsible for drug substance/drug product quality management:- Quality Risk Assessments;- Apply Lean tools in problem solving (8D) and continuous improvement activities;- Quality activities management such as CAPA.
- Promote the importance of high quality levels and the importance of a continuous improvement culture in all core company activities;
- Support client audits and Health Authority inspections;
- Product quality life cycle continuous management, continuously evaluate trends and process capability evaluation throughout statistical analysis;
- Work with operational departments to establish procedures, standards and systems that assure and improve compliance with the cGMP;
- Determine, negotiate and agree in-house quality procedures, standards and/or specifications;
Jun 2017 - Present
