Quality Assurance Senior Specialist

Quality Assurance Senior Specialist

The Quality Assurance Senior Specialist plays a pivotal role in ensuring our organization adheres to stringent quality assurance standards and regulatory requirements, specifically those related to controlled drugs. This strategic position oversees a broad spectrum of responsibilities, including inventory management, regulatory coordination, quality investigations, and driving continuous improvement initiatives, all while supporting compliance with Saudi Food and Drug Authority (SFDA) regulations and Good Distribution Practices (GDP).

• Key Responsibilities:
• Manage the custody and inventory of controlled drugs within our company and SFDA systems.
• Serve as the primary point of contact with the SFDA, facilitating inquiries, reporting, system management, and stock accountability.
• Act as the main liaison with Commercial, Planning, and Customer teams for controlled drug sales requests.
• Manage quality deviations and customer complaints, conducting 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 regulatory compliance.
• Prepare and maintain documentation and records for internal and external quality audits.
• Conduct quality awareness initiatives and training programs on 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: We seek a motivated professional with a Bachelor's degree in Pharmacy, Quality Management, Life Sciences, or a related field, and a minimum of 4 years of experience in Quality Assurance, preferably within the pharmaceutical or healthcare industry. Familiarity with warehouse operations and GDP is essential. Experience working with SFDA regulations and systems is preferred. Strong analytical, problem-solving, and project management skills are required, along with excellent organizational skills and the ability to work independently and collaboratively in a cross-functional environment. Proficiency in Microsoft Office applications and reporting dashboards is necessary.

Requirements: Fluency in both Arabic and English is required. Strong communication and stakeholder management skills are crucial, along with a demonstrated commitment to quality, compliance, and continuous improvement.