Position Summary
Executive - QA
Location: DIC, Dubai
Reporting to: Plant Lead - Quality
ROLE CONTEXT & PURPOSE
As part of a greenfield pharmaceutical manufacturing setup, the
Executive - QA will play a crucial role in implementing and overseeing robust quality assurance practices. This includes ensuring adherence to global quality standards, driving compliance with regulatory requirements, and fostering a culture of continuous quality improvement within the organization. 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.
Key Responsibilities
- 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
EXPERIENCE + EXPOSURE + EDUCATION
- 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.
Key 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.
- Analytical mindset with the ability to identify and resolve quality challenges effectively.
- Excellent documentation, organizational, and leadership skills.
Key Competencies
- 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.
