Science & Pharmaceutical JobsQuality Responsible Person – Dubai

  • SJ50478
  • Permanent
  • International

Collins McNicholas

JOB TITLE: Quality Responsible Person – GDP
COMPANY: Global Biopharmaceutical Company
LOCATION:  Dubai
JOB TYPE:   Permanent

JOB SUMMARY
This is an exciting opportunity for a Qualified Pharmacist within the UAE to manage QA GDP within this global biopharmaceutical company.

JOB DESCRIPTION

1. Ensure that a Quality Management System is implemented and maintained in the local affiliate

2. Ensures implementation of following Quality Operations:
• Warehouse quality oversight, including approval of products to the markets as well as ensure export compliant to markets’ quality relevant regulations
• Suppliers management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status
• Distributor oversight: periodic distributor verification compliance
• Product Quality status and batch release or approval to the markets
• Local release process
• Handles compliance/quality issues with the impacted market team
• Ensures On Hold products request are observed
• Coordinates and promptly perform any market action operation, recall, for medicinal products. Mock recalls
• Decides on the final disposition of rejected, recalled or falsified products
• Approval of the returns to saleable stock, according to internal requirements
• Support Supply Chain to avoid Back Orders
• Provide quality input on shortage situations and oversight reporting to Health Authority
• Medical samples Quality distribution oversight
• Supports of sampling requested by HA(product, procedures, reference substances)
• Keeps appropriate records of any delegated duties

3. Facilitate that internal requirements are implemented in the Local Distribution Centre

4.Quality Risk Management

5. Inspections and Regulatory Surveillance

EDUCATION AND EXPERIENCE

Pharmaceutical degree and certifications required by the local UAE regulation (MOH licence valid in UAE is a must)
• 5-7 years of experience within the quality control function of the pharmaceutical health care industry and regulatory agencies
• Extensive knowledge and experience in quality system development, pharmaceutical health care operations, quality control, distribution and International regulations are essential.
• Proficient in GMPs, GDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations; and requirements for pharmaceutical products distribution
• Strong negotiating skills for interface with Health Authorities and market business functions
• Ability to effectively communicate ideas, lead and persuade others to accomplish challenging goals and objectives.
• Excellent verbal, written and presentation skills in English and Arabic; the ability to deal effectively with all levels of management. French language is an additional asset
• Demonstrate the ability to switch priorities and manage more than one project at the time. Ability to plan and conduct projects within a multi-disciplinary environment, inquisitive, science technology-oriented individual but practical

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