Review Standard Operating Procedures (SOPs), validation protocols, and associated documentation to ensure regulatory and internal compliance.
Review qualification and validation reports, and technical reports, ensuring accuracy,completeness, regulatory compliance.
Review deviation investigations, root cause analysis and ensure timely documentation and closure in the Quality Management System (QMS).
Monitor and coordinate Corrective and Preventive Actions (CAPA), maintain CAPA documentation, and verify effectiveness in alignment with regulatory requirements.
Coordinate Quality Risk Management (QRM) activities, including development of annual risk management plans, review and execution of risk assessments, and preparation of periodic risk reports.
Provide support to ensure effective implementation and adherence to quality systems and contribute to continuous improvement initiatives through enhanced process understanding and collaboration.
Support manufacturing site activities and new process introductions, ensuring quality system readiness and compliance.
Review and work procedures and policies to reflect mitigation strategies and evolving regulatory requirements.
Monitor quality metrics, analyze trends, and prepare comprehensive reports to support management reviews and decision-making.
Perform additional quality-related tasks and responsibilities assigned by direct manager.
Academic & Professional Experience required:
Minimum 3 years of experience in Quality Assurance in a Good Manufacturing Practices (GMP) environment in Pharma industry.
Proficiency in computer, MS Office knowledge.
Experience in electronic systems like SAP, DCM, etc.
Advanced written and spoken fluent English and Arabic.
