Holding - QA Supervisor

Job description

Acts as the Qualified Person and primary SFDA contact for the MDC warehouse and backs up Controlled drugs management. Ensures implementation of approved quality procedures in daily warehouse operations within his region. Supports review and proper implementation of quality contracts with vendors and clients. Monitors and manages complaints, ensuring timely investigation and effective resolution to prevent recurrence. Oversees deviation management, ensuring thorough investigations, root cause analysis, and corrective actions. Implements and monitors CAPA plans to address deviations, ensuring timely closure and effectiveness. Ensures proper handling of recall requests from SFDA and suppliers, with timely execution and documentation. Conducts regular warehouse inspections to verify compliance with quality standards and operational procedures. Assists in reviewing and updating quality policies and procedures to align with regulatory requirements and best practices. Supports review and verification of labeling and co-packing processes to ensure compliance with quality and regulatory requirements. Ensures monitoring of safety requirements in the warehouse and reports any related deviation. Ensures monitoring of temperature and humidity in the warehouse and reports any related deviation. Ensures compliance with quality standards in inbound and outbound warehouse operations.

Requirements

• Bachelor's degree in a related field such as Pharmacy, quality assurance, engineering, or sciences
• 3+ years of experience
• familiarity with warehouse operations and basic knowledge of quality practices including quality standards and Good Distribution Practice
• strong communication and training skills to influence and engage employees
• problem-solving and decision-making skills in high-pressure situations
• ability to work independently and as part of a team
• proficiency in common software applications and dashboard reporting.

Skills