To Implement and maintain a Quality Management System compliant with GMP/GDP requirements. To ensure compliance of the warehouse to pharmaceutical requirement as stipulated by SAHPRA.

Key Responsibilities
• Follow and resolve all distribution quality queries in the shortest possible timeframe within policy framework
• Display a professional attitude when responding to customer’s needs
• Propose and continuously develop methods to improve customer services
• Respond to distribution quality related complaints and liaise with customer and regulatory affairs
• Interact with SAHPRA & SAPC
• Liaise with Managers relating to quality issues
• Ensure that site is informed and aware of the Quality policies
• Direct and manage the Quality Management System
• Monitor key performance areas relating to quality
• Establish quality plans for the warehouse
• Generate, maintain, monitor and review SOP’s to ensure effectiveness
• Ensure training of quality procedures for site
• Ensure training of desired level of GMP/GDP
• Develop and train staff
• Ensure availability of training records for inspection
• Direct and manage implementation of applicable quality standards
• Monitor and review calibration and validation status of equipment
• Ensure effective Change Control and Deviations control and management system is in place.
• Review processes to ensure compliance for audits
• Ensure compliance to procedures, GMP/ GDP and regulatory requirements.
• Monitor temperature and humidity; analyses data and compile reports
• Ensure Non-conformances are recorded, investigated and corrective action implemented
• Plan internal audits
• Conduct internal audits - ongoing
• Write reports and follow up on corrective actions
• Feedback to senior management
• Facilitate Vendor audits as when required
• Compliance to procedures, GMP/GDP and regulatory requirements
• Compile and maintain site master file
• Review and inspect for regulatory compliance
• Familiarize with PIC, FDA and MHRA / SAHPRA standards
• Ensure compliance to regulations for relevant markets
• Report to Manager regarding operational requirements
• Maintain relevant delegation letters
• Maintain licenses for premises and personnel to SAHPRA, SAPC and DOH
• Ensure SLA’s are in place with relevant Service Providers
• Review and maintain Technical Agreements/SLA’s to ensure quality matters relating to warehousing / distribution of pharmaceutical goods are clearly addressed
• Stock losses should be minimized by implementation of appropriate security measures
• Monitor stock discrepancies by reviewing inventory adjustments performed and cycle count results
• Report on stock losses using internal reporting structures, and when required, the relevant regulatory authorities.
• Compile Annual Reports for submission to the Department of Health (DOH)
• Oversee compilation of monthly reports on pharmaceuticals
• Oversee training for site both internal and external
• Oversee SOP training
• Ensure compliance with SHE requirement
• Ensure that Health and Safety procedures are adhered to and correct PPE are used
• Repair and maintenance of equipment and facilities