Executive - QA

Job Description

Position Summary

Executive - QA

Reporting to: Plant Lead - Quality

ROLE CONTEXT & PURPOSE

The incumbent will focus on quality systems, risk management, and regulatory inspections, setting a strong foundation for the QA framework in a newly established facility.

• 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 CAPAs 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.

CANDIDATE SPECIFICATION

• 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.
• Analytical mindset with the ability to identify and resolve quality challenges effectively.
• Excellent documentation, organizational, and leadership skills.

• Strategic thinking with an eye for detail.
• Strong collaboration and communication skills to work across functions.
• Resilience and adaptability to navigate the complexities of a greenfield environment.
• Commitment to fostering a quality-centric organizational culture.