Improve the quality management system processes by rewriting and stream lining several existing procedures to meet industry and regulatory requirements.
Manage the development, implementation and certification of a complete Quality Management System compliant with ISO 9001.
Ensure QMS compliance with relevant regulations and standards, maintaining updated knowledge of changes.
Developed presentations and reporting mechanism for Quality Management System metrics.
Managing the system of Job Descriptions and Organogram
Provide guidance and direction to the QMS & Documentation team to ensure proper coverage of all aspects in a GMP change
Lead the preparation, management, execution and support of external regulatory agency inspections and customer audits.
Oversee the Quality Management Plan Implementations and provide suggestions
Leading the Recall & Complaint functions and ensuring proper closure of topic
Provides leadership to achieve quality goals, develops and implements an ongoing development program for QMS processes while designing measures to monitor the effectiveness of the OMS itself and drive remediation for improvement.
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