Quality Assurance Specialist

Catafago

System Implementation and Documentation:

• Ensure that the quality management system (QMS) aligns with ISO 9001:2015 and Lebanese GSDP requirements.
• Develop and update standard operating procedures (SOPs), work instructions, and quality manuals that align with ISO 9001 and GSDP guidelines.
• Establish and maintain a robust document control system to ensure that all documents (SOPs, batch records, certificates of analysis, etc.) are regularly reviewed, approved, and kept up-to-date.

Training and Awareness:

• Provide training on ISO 9001 standards, GSDP requirements, and any specific pharmaceutical industry compliance standards to employees at all levels.
• Organize ongoing training and awareness programs to ensure that employees are kept up to date with changes in the standards, regulations, and internal procedures.

Quality Assurance and Monitoring:

• Conduct internal audits of the quality management system to ensure compliance with ISO 9001 and GSDP guidelines. These audits should be performed regularly (annually or bi-annually) and cover all relevant processes such as receiving, storage, distribution, and dispatch.
• Verify that the distributor s processes are in compliance with GSDP requirements, including proper storage conditions, handling of pharmaceuticals, and traceability of products.
• Track, monitor, and resolve non-conformities through Corrective and Preventive Actions (CAPA) processes to maintain ongoing compliance with both ISO 9001 and GSDP.

Risk Management:

• Perform risk assessments related to the distribution process, including storage, transportation, and handling of pharmaceutical products.
• Develop and implement risk mitigation strategies to address identified risks, ensuring that they do not affect the quality or integrity of the pharmaceutical products.
• Continuously monitor potential risks (e.g., temperature excursions, supply chain disruptions) and take corrective actions as needed.

Supplier and Vendor Management:

• Evaluate and qualify suppliers to ensure they meet both ISO 9001 and GSDP requirements. This includes assessing the quality systems, performance, and regulatory compliance of suppliers.
• Conduct regular audits of key suppliers and service providers to ensure they comply with relevant quality and regulatory standards.
• Monitor the performance of suppliers and logistics partners to ensure that they maintain compliance with contractual terms, quality requirements, and regulatory standards.

Regulatory Compliance and Reporting:

• Ensure that all regulatory requirements from Lebanese health authorities (e.g., Ministry of Public Health) and international bodies (e.g., WHO) are met in the distribution processes.
• Assist in maintaining and renewing ISO 9001 certification and any other relevant certifications (e.g., GSDP) through audits and continuous monitoring.
• Prepare and submit reports for internal stakeholders, regulatory bodies, and certification bodies, ensuring accurate documentation of compliance efforts and audits.

Product Traceability and Recall Management:

• Establish and maintain a system for the traceability of products from receip