Overview

Our client is looking for an Executive in the Quality Assurance to play a key role in for maintaining the integrity of our products and services, thus protecting our brand reputation and ensuring customer satisfaction within a greenfield pharmaceutical setup.

Key Responsibility

• Develop and maintain the Quality Management System (QMS), ensuring compliance with global and UAE-specific regulatory requirements.
• Define and monitor key quality indicators (KQIs) to assess the effectiveness of quality systems.
• Lead the development of risk assessment and mitigation strategies for quality processes.
• Ensure alignment with UAE Ministry of Health guidelines, as well as international standards like WHO, EMA, and US FDA.
• Oversee the preparation of dossiers and quality documentation for regulatory submissions and registrations.
• Act as a point of contact during regulatory inspections, ensuring timely responses and implementing post-audit corrective actions.
• Approve and monitor the execution of validation protocols for equipment, processes, and analytical methods.
• Conduct periodic reviews of quality-related deviations, complaints, and CAP as to identify systemic issues and drive improvements.
• Manage quality agreements with external vendors and suppliers to ensure compliance with set standards.
• Design and deliver training programs focused on regulatory updates, quality processes, and SOP adherence for QA and other relevant teams.
• Promote a culture of proactive quality assurance through regular workshops and knowledge-sharing sessions.
• Work closely with the QC, production, and engineering teams to ensure seamless integration of quality principles across departments.
• Represent the QA team in cross-functional meetings to address quality-related concerns and propose actionable solutions.

Must Have

• Bachelor’s or master’s degree in pharmacy, Biotechnology, Chemistry, or a related field.
• 5-7 years of experience in a Quality Assurance role, preferably in a pharmaceutical manufacturing setup with prior greenfield project exposure.
• Strong expertise in QMS, risk management frameworks, and global regulatory standards, with specific knowledge of UAE Ministry of Health compliance.
• Proficiency in handling quality audits, regulatory inspections, and compliance activities.

Skills

• Strong expertise in QMS, risk management frameworks, and global regulatory standards, with specific knowledge of UAE Ministry of Health compliance.
• Proficiency in handling quality audits, regulatory inspections, and compliance activities.
• Define and monitor key quality indicators (KQIs) to assess the effectiveness of quality systems.
• Lead the development of risk assessment and mitigation strategies for quality processes.
• Ensure alignment with UAE Ministry of Health guidelines, as well as international standards like WHO, EMA, and US FDA.