Quality System Specialist
We presently have a Quality System Manager with A CDMO; you will be integral in maintaining a comprehensive understanding of current Good Manufacturing Practices (GMP) and driving continuous improvement in performance and quality.
Your role will involve ensuring compliance with regulatory requirements and industry standards in all GMP-related activities.
You will contribute to the consistent implementation of Quality System tools and documentation, design and develop training programs, and define and execute the self-inspections annual program.
Additionally, you will actively participate in audits / inspections within your area of responsibility, perform vendor assessment and qualification, and oversee corrective and preventive actions (CAPAs), deviations, Lab investigations, and Change Controls.
Your role will also include providing Quality review and approval for deviations reports, CAPAs, and Change Controls related to the Quality System, as well as reviewing and approving Water sampling and Environmental Monitoring (EM) results.
Redacting and / or reviewing Standard Operating Procedures (SOPs) related to the Quality System will be part of your responsibilities.
You will integrate risk management and LEAN management principles into the Quality System, perform data trending analysis on GMP-related processes (e.
g., Water sampling, EM), and generate Key Performance Indicators (KPIs).