Job Description

Roles & Responsibilities

Develop, implement, and maintain a robust quality management system (QMS) in compliance with regulatory requirements.
Establish standard operating procedures (SOPs) for quality assurance processes and ensure adherence across departments.
Monitor regulatory requirements and industry standards related to pharmaceutical products.
Ensure compliance with Good Distribution Practices (GDP), Good Storage Practices (GSP), and other relevant regulations.
Conduct internal audits to assess compliance with quality standards and identify areas for improvement.
Coordinate external audits from agencies or customers and facilitate audit responses.
Conduct periodic inspections and internal audits to ensure compliance with standard operating procedures (SOPs) and quality requirements.
Identify areas for improvement and implement corrective actions as needed.
Evaluate and qualify suppliers and service providers to ensure they meet quality standards.
Establish quality agreements with suppliers.
Coordinate with the suppliers to ensure that the existing SOP's meet the suppliers’ requirements.
Conduct annual product reviews in compliance with regulations set by the Ministry of Health (MOH) to assess product quality and performance.
Monitor and evaluate the performance of the company's quality system and advise senior management on areas for improvement.
Interact with health authorities such as MOH, DHA, and HAAD regarding quality-related issues and ensure compliance with regulatory requirements.
Oversee the maintenance and renewal of Drug Establishment Licenses to ensure continued regulatory compliance.
Coordinate with departments and suppliers to facilitate prompt and safe product recalls as requested by suppliers or health authorities.
Ensure adherence to supplier standards and regulatory requirements during recall procedures.
Manage the release of samples and ensure proper handling and storage of expired goods and quarantined stocks.
Oversee the proper destruction of expired products in accordance with regulatory guidelines.
Collaborate with the Warehouse to develop training programs for drivers, store helpers, and delivery boys on material handling, customer behavior, and complaint handling.
Assist the sales division in developing training programs for salespeople to handle quality and product complaints effectively and report them appropriately.
Ensure all products are stored, handled, and distributed according to supplier standards, as well as Good Warehouse Practices (GWP) and Good Distribution Practices (GDP).

Desired Candidate Profile

Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field. Advanced degree preferred.
Minimum of 8+ years of experience in quality assurance or regulatory affairs, preferably in the pharmaceutical industry.
In-depth knowledge of regulatory requirements and quality standards (e.g., MOH, GMP, GDP).
Strong leadership, communication, and interpersonal skills.
Experience in conducting inspections, audits, and managing regulatory interactions.
Certification in quality management (e.g., ASQ Certified Quality Manager) is desirable.
Strong understanding of pharmacovigilance regulations and guidelines.
UAE Driving License may be required

Quality Manager
Confidential Company

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