Key responsibilities:

• Ensures compliance with GDP and local regulatory requirements for transportation (in- and outbound activities), storage and product handling.
• Ensures that third-party logistics (3PL) provider complies with GDP and local regulatory requirements and aligns with Quality Agreement.
• Monitors all tasks delegated to 3PL and listed in this Agreement and takes action if notices any non-compliance or gap.
• Collaborates with and supports the relevant QRP, regional Quality Management, supply chain functions and other internal departments of our Company on quality matters and makes notifications as required.
• External communication and collaboration:
  • Communicates with the competent Health Authority in UAE.
  • Communicates with service providers and subcontractors.
  • Communicates with and supports representatives of target markets/target countries.
  • Communicates with Marketing Authorization Holders.
• Manages and participates in audits/inspections, recalls.
• Writes, approves & reviews procedures with GDP impact.
• Performs self-inspection and deviation investigation.
• Manages, documents and monitors deviation, CAPA, change control, risk assessment.
• Ensures facility, equipment, system validation is performed, and results meet requirements.
• Reviews and approves contracts that concern quality assurance.
• Maintains the Document Management System.
• Applies principles of Quality Risk Management.
• Handles the complaints reported from the markets supplied and in accordance with Manufacturing Division complaint handling process.
• Assesses temperature excursions.
• Manages and documents all relevant tasks with GDP impact.
• Management Review and Quality Metrics.

The responsibilities above also include authority to issue instructions, act and take decisions to fulfill HA requirements and to safeguard patient health. The responsible person must always make decisions based on their own evaluation and the information they have acquired.

• Desired Candidate Profile