The Role
Supervise pharmaceutical warehouse quality operations, serving as Qualified Person and SFDA contact. Ensure compliance with quality procedures, Good Distribution Practice, safety, temperature and humidity controls, labeling, co-packing, inbound and outbound processes. Manage complaints, deviations, root-cause investigations, CAPA plans, recalls, inspections, vendor quality agreements, and regulatory documentation. Support policy updates and employee training.
Summary Generated by Built In
Responsibilities
- Act as the Qualified Person and primary SFDA contact person for MDC warehouse and backup for FMT Controlled drugs management.
- Ensure the implementation of approved quality procedures in daily operations for warehouse under his region
- Support in reviewing and ensuring the proper implementation of quality contracts with vendors and clients
- Monitor and manage complaints, ensuring timely investigation and effective resolution to prevent recurrence.
- Oversee the management of deviations, ensuring thorough investigations, root cause analysis, and corrective actions.
- Implement and monitor Corrective and Preventive Action (CAPA) plans to address deviations, ensuring their timely closure and effectiveness.
- Ensure proper management of recall requests from the SFDA and suppliers, ensuring timely execution and documentation.
- Conduct regular inspections of warehouses to verify compliance with quality standards and operational procedures.
- Assist in reviewing and updating quality policies and procedures to align with regulatory requirements and best practices.
- Support the review and verification of labelling and co-packing processes to ensure compliance with quality and regulatory requirements.
- Ensure monitoring safety requirement at the warehouse and report any related deviation.
- Ensure monitoring Temperature and Humidity at the warehouse and report any related deviation.
- Ensure compliance with quality standards in inbound and outbound operations within warehouses.
- Bachelor's degree in a related field, such as Pharmacy, quality assurance, engineering, and 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 Required
- Bachelor's degree in Pharmacy, Quality Assurance, Engineering, Sciences, or a related field
- At least 3 years of relevant experience
- Familiarity with warehouse operations
- Basic knowledge of quality practices, quality standards, and Good Distribution Practice
- Strong communication and training skills
- 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
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The Company
What We Do
Farouk, Maamoun, Mohammed Said Tamer Industries Ltd. (FMTI) is a Saudi holding and investment company within Tamer Group. Its stated focus is investing in industrial projects related to healthcare and consumer goods. FMTI is also identified as a majority shareholder in Saudi Arabian Japanese Pharmaceutical Co. Ltd., linking it to pharmaceutical manufacturing and the broader healthcare and consumer-products activities of Tamer Group in Saudi Arabia.
