Pharmacy Quality Assurance – Dubai

Pharmacy Quality Assurance wanted in Dubai with a leading Pharma company to serve as the designated Pharmacist in Charge (PIC) and provide quality oversight for a newly established Middle East & Africa (MEA) Regional Distribution Center in the UAE.

The role is responsible for ensuring compliance with Good Distribution Practices (GDP), UAE pharmaceutical regulations, regulatory authority requirements, and company Quality standards covering the storage, transportation, handling, and distribution of pharmaceutical products.

The position will work closely with Quality, Supply Chain, Regulatory, 3PL providers, Marketing Authorization Holders, healthcare authorities, and other stakeholders to maintain a robust pharmaceutical quality management system and protect product quality and patient safety.

Key Responsibilities

Pharmaceutical Quality Assurance & GDP Compliance -Pharmacy Quality Assurance

• Ensure compliance with Good Distribution Practices (GDP) and applicable UAE regulatory requirements for pharmaceutical storage, transportation, handling, and distribution.
• Provide quality oversight of inbound and outbound pharmaceutical distribution activities.
• Ensure pharmaceutical products are handled, stored, transported, and distributed under appropriate controlled conditions.
• Monitor compliance with company Quality standards and applicable local regulations.
• Ensure all GDP-related activities are properly documented, controlled, and maintained.

Pharmacist in Charge Responsibilities

• Act as the designated Pharmacist in Charge (PIC) for the UAE distribution operation, subject to applicable regulatory requirements.
• Exercise appropriate professional authority to ensure compliance with Health Authority requirements.
• Take independent quality and regulatory decisions where required to safeguard product quality and patient health.
• Maintain effective communication with the relevant UAE Health Authority and respond to regulatory requirements.

Pharmacy Quality Assurance Partner

• Ensure third-party logistics (3PL) providers operate in compliance with GDP and applicable UAE regulatory requirements.
• Monitor 3PL performance against approved Quality Agreements and contractual quality requirements.
• Review and monitor delegated quality activities and identify gaps, deviations, and non-compliance.
• Ensure appropriate corrective and preventive actions are implemented where deficiencies are identified.
• Support qualification, monitoring, auditing, and performance evaluation of logistics service providers.

Quality Management System

• Manage and monitor deviations, CAPA, change controls, risk assessments, complaints, and other quality events.
• Conduct and support deviation investigations and root-cause analysis.
• Apply Quality Risk Management (QRM) principles to pharmaceutical distribution activities.
• Develop, review, approve, and maintain procedures and SOPs having GDP or Quality impact.
• Maintain the Quality and Document Management System.
• Ensure quality records are complete, accurate, controlled, and readily available for regulatory inspection.

Audits, Inspections & Regulatory Affairs

• Plan, coordinate, and participate in internal and external audits and regulatory inspections.
• Conduct periodic self-inspections of the distribution operation.
• Support regulatory inspections and ensure timely implementation of inspection-related corrective actions.
• Communicate with UAE Health Authorities and other relevant regulatory stakeholders.
• Coordinate with service providers, subcontractors, Marketing Authorization Holders, and representatives from target markets/countries.
• Manage and support pharmaceutical product recalls and related quality activities.

Temperature Control & Product Quality

• Assess and manage temperature excursions affecting pharmaceutical products.
• Ensure appropriate investigation, impact assessment, documentation, and disposition decisions are completed.
• Monitor temperature-controlled storage and transportation systems.
• Ensure appropriate controls are established for products requiring specific environmental conditions.

Validation & Qualification

• Ensure appropriate qualification and validation of facilities, equipment, systems, and relevant processes.
• Review validation documentation and verify that results meet applicable regulatory and Quality requirements.
• Ensure computerized systems and other critical systems supporting GDP operations are appropriately controlled.

Complaints & Market Quality

• Handle and investigate product quality complaints received from supplied markets.
• Coordinate complaint investigations in accordance with the applicable company complaint-handling process.
• Ensure appropriate escalation, documentation, investigation, and corrective action for quality complaints.

Quality Agreements & Contracts

• Review and approve Quality Agreements and contracts that have a pharmaceutical Quality or GDP impact.
• Ensure responsibilities between the company, 3PL providers, service providers, and other partners are clearly defined.
• Monitor compliance with agreed quality responsibilities.

Quality Performance & Management Review

• Monitor relevant Quality Metrics and KPIs for the distribution operation.
• Prepare and contribute to Quality Management Reviews.
• Identify quality trends, recurring issues, and opportunities for continuous improvement.
• Ensure appropriate escalation of significant quality risks to regional and global Quality functions.

Licensing – Pharmacy Quality Assurance

• Bachelor’s degree or higher in Pharmacy from a recognized university.
• Must hold a valid UAE Pharmacist License issued by an applicable health authority, such as:
  • Ministry of Health and Prevention (MOHAP)
  • Dubai Health Authority (DHA)
  • Department of Health – Abu Dhabi (DoH)
• Must meet the applicable UAE regulatory eligibility requirements to serve as the designated Pharmacist in Charge.
• Relevant experience in pharmaceutical wholesale, distribution, Quality Assurance, or GDP operations is strongly preferred.

Required Experience & Knowledge

• Experience in pharmaceutical wholesale, distribution, warehousing, or Quality Assurance.
• Strong knowledge of Good Distribution Practices (GDP) and pharmaceutical quality systems.
• Good understanding of pharmaceutical warehouse and distribution operations.
• Experience with deviation management, CAPA, change control, risk assessment, complaints, audits, inspections, and recalls.
• Knowledge of temperature-controlled pharmaceutical storage and transportation.
• Experience working with 3PL providers and Quality Agreements is an advantage.
• Understanding of UAE pharmaceutical regulatory and Health Authority requirements.
• Strong documentation and quality-system management skills.

Required Skills

• Pharmaceutical Quality Assurance
• Good Distribution Practices (GDP)
• Distribution Management
• Regulatory Compliance
• Quality Auditing
• Pharmaceutical Quality Systems
• Quality Risk Management
• CAPA & Deviation Management
• Change Control
• Complaint & Recall Management
• Temperature Excursion Assessment
• Quality Agreements
• Warehouse & Distribution Operations
• Regulatory Inspection Management
• Documentation Management
• Strategic Planning
• Quality Metrics & Continuous Improvement
• Stakeholder Management

Job Qualifications

The ideal candidate is a UAE-licensed Pharmacist with pharmaceutical distribution or Quality Assurance experience, strong knowledge of GDP, and the professional competence required to act as a Pharmacist in Charge. The candidate should be confident in dealing with regulatory authorities, 3PL partners, audits, quality investigations, and cross-functional stakeholders while maintaining a strong focus on pharmaceutical product quality and patient safety.