Quality Assurance Specialist

The QA Specialist is responsible for ensuring the compliant custody, inventory control, storage, and distribution of controlled drugs in accordance with SFDA regulations and Good Distribution Practice (GDP) requirements. The role serves as the primary liaison with the SFDA and internal stakeholders, overseeing quality incidents, complaints, recalls, audit readiness, and continuous improvement initiatives to ensure product integrity, regulatory compliance, and operational safety.

Key Responsibilities

• Manage the custody and inventory of controlled drugs across the company’s inventory system and the SFDA system, ensuring accurate records and regulatory compliance.
• Act as the primary point of contact with the SFDA for regulatory inquiries, reporting, system updates, and stock accountability.
• Coordinate with Commercial, Planning, and Customer teams to manage customer sales requests for controlled drugs.
• Manage deviations and complaints, including investigations, root cause analysis, corrective and preventive actions (CAPA), and follow-up to prevent recurrence.
• Oversee the preparation, handling, storage, and distribution of controlled drugs, ensuring stock accuracy and compliance with established procedures and regulations.
• Maintain accurate documentation, records, and procedures to ensure readiness for internal and external audits.
• Support quality risk assessments, risk mitigation, trend analysis, and recommendations for corrective actions.
• Support the implementation of quality assurance initiatives, process changes, and continuous operational improvements.
• Conduct training sessions and provide ongoing guidance to employees on Good Distribution Practice (GDP), Good Storage Practice (GSP), and relevant quality requirements.
• Monitor warehouse safety and quality requirements, identify deviations, and ensure timely reporting and resolution.
• Manage product recalls initiated by the SFDA or suppliers, ensuring timely execution, appropriate communication, and complete documentation.

Qualifications & Experience

• Bachelor’s degree in Pharmacy or a related field.
• A valid and active professional pharmacy licence is mandatory.
• At least 1 year of relevant experience.
• Familiarity with warehouse operations and basic knowledge of quality practices, quality standards, and Good Distribution Practice (GDP).
• Working knowledge of both Arabic and English.
• Strong analytical, problem-solving, and decision-making skills, with excellent attention to detail.
• Effective communication and interpersonal skills, with the ability to work independently and collaboratively.