Establish compliant Quality management system to help facilitate timely, accurate and sustained decision making to assure appropriate and compliant outcomes.
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.
Responsible for the Development and improvement of the Documentation team to ensure best practices are followed
Innovate the process of QMS & Documentation teams to reach compliance and support digitalization process
Support the implementation of Data Integrity principals
Close out of all change controls to ensure proper evidence in place
Review CAPA for extensions and closure of regulatory CAPA
Handle strategic change controls assessments and approvals
Follow up and resolve escalations related to batch printing
Manage escalations related to the QMS and regulatory commitments and properly communicate outcome to upper management
Qualification/Functional Knowledge
Bachelor/Master degree in Pharmaceutical/ Life Sciences or Engineering discipline.
Minimum 10 years of experience with at least 7 years in management roles in pharmaceutical industry sector. Minimum 5 years of experience in paper & electronic Data Integrity.
Proven track record in systems initiation and KPI design
Ability to create cross functional relations and manage conflicts
Capability to provide quality solutions and managing crisis
Led successful quality improvement projects and cost saving procedures permitting company to meet and exceed goals in competitive environment.
Strong regulatory knowledge for multiple markets including GCC, EU, USA, WHO.
Developed various processes and procedures giving training to engineering and manufacturing with quarterly presentations to Divisional Directors and Managers.
