Quality Assurance Senior Specialist

Job Purpose

The QA Senior Specialist is responsible for ensuring compliance with quality assurance standards and regulatory requirements related to controlled drugs. This role oversees inventory management, documentation, regulatory coordination, quality investigations, and continuous improvement initiatives while supporting compliance with SFDA regulations and Good Distribution Practices (GDP).

Key Responsibilities

• Manage the custody and inventory of controlled drugs within the company and SFDA systems.
• Act as the primary point of contact with the Saudi Food and Drug Authority (SFDA) regarding inquiries, reporting, system management, and stock accountability.
• Serve as the main liaison with Commercial, Planning, and Customer teams for controlled drug sales requests.
• Manage quality deviations and customer complaints related to controlled drugs, including investigations, root cause analysis, CAPA implementation, and follow-up.
• Obtain import permits and oversee product clearance through the SFDA system.
• Supervise the preparation and distribution of controlled drugs, ensuring inventory accuracy and compliance with applicable regulations.
• Prepare and maintain documentation and records to ensure readiness for internal and external quality audits.
• Conduct quality awareness initiatives and training programs on Good Distribution Practices (GDP) and quality standards.
• Support risk assessments for quality processes and recommend corrective and preventive actions.
• Drive continuous improvement initiatives to enhance quality assurance operations.
• Monitor warehouse safety requirements and report any quality or safety deviations.
• Coordinate product recall activities with SFDA and suppliers, ensuring timely execution and proper documentation.

Qualifications & Experience

• Bachelor's degree in Pharmacy, Quality Management, Life Sciences, or a related field.
• Minimum of 4 years of experience in Quality Assurance, preferably within the pharmaceutical or healthcare industry.
• Familiarity with warehouse operations and Good Distribution Practices (GDP).
• Experience working with SFDA regulations and systems is preferred.
• Strong analytical, problem-solving, and project management skills.
• Excellent organizational skills with strong attention to detail.
• Ability to work independently and collaboratively in a cross-functional environment.
• Proficiency in Microsoft Office applications and reporting dashboards.

Requirements

• Working proficiency in both Arabic and English.
• Strong communication and stakeholder management skills.
• Commitment to quality, compliance, and continuous improvement.