Manufacturing Quality Systems Specialist

• 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.