Qa Manager à Émirats arabes unis

Oversee, maintain, and continuously improve the QMS covering all GxP and health-regulated activities related to the storage, distribution, and commercialization of healthcare products within the UAE, ensuring compliance with MOH, GDP, and principal company requirements.

Lead the QA team in implementing and maintaining quality systems, procedures, and documentation aligned with regulatory and corporate policies.

Develop, implement, and enforce Quality Assurance standards and SOPs, ensuring operational readiness for inspections by regulatory authorities and principal company auditors.

Oversee all QMS activities, including CAPAs, deviations/investigations, change control, document control, and product release according to partner and regulatory obligations.

Implement and manage best practice systems across all warehouse and distribution operations, covering delivery, storage, temperature control, expiry management, damage handling, and disposal, ensuring adherence to quality and regulatory standards.

Monitor temperature control mechanisms within the warehouse, ensuring operations stay within validated parameters and defined guidelines.

Ensure compliance with Good Distribution and Storage Practice (GDSP) guidelines issued by MOH, fostering operational excellence across the supply chain.

Collaborate with cross-functional teams to ensure quality-related contractual obligations are fulfilled across business partners, vendors, and internal functions.

Oversee the qualification process of vendors, verifying their quality systems and compliance with GDP, regulatory, and contractual requirements.

Manage and oversee internal and external audits, ensuring inspection readiness, facilitating successful inspections by MOH, Municipality, Quality Assurance, and principal companies, and minimizing violations or penalties.

Facilitate and conduct training programs, providing tools, techniques, and guidance to ensure team achievement and maintenance of high-quality standards and regulatory compliance.

Monitor and report quality metrics to senior management, providing insights and recommendations for quality improvement and decision-making.

Identify and report quality violations, lead root cause investigations, and implement effective CAPAs to address non-conformances.

Ensure timely, accurate submissions of regulatory filings and reports, maintaining adherence to deadlines and compliance requirements.

Manage all Quality Agreements with business partners and vendors, ensuring their validity, updates, and relevance.

Oversee the execution of the Employee Training Program to maintain continuous qualification of staff in accordance with standards.

Identify, assess, and manage quality risks, escalating issues to senior management as needed.

Oversee the management of product recalls, returns, and destruction, including regulatory notifications, dispatch of recall letters, and coordination with MOH approval and collection processes in line with SOPs.

• Manage import and export permits and approvals for shipment release from MOH.
• Coordinate with Logistics for import permit requirements and with principal companies for documentation.
• Ensure necessary documents are attached before submission for registration (e.g., registration certificate, packing list).
• Coordinate with MOH officials for timely approval of import/export activities.
• Verify shipment details against import permits before MOH submission.
• Handle submission of release forms, supplier invoices, and batch samples for MOH approval.
• Re-export rejected items and liaise with MOH officials.
• Update logistics on shipment details and ensure timely deliveries.
• Ensure cold storage goods are received in good condition as per quality procedures and policies.
• Monitor semi-controlled goods from importation to dispatch, ensuring compliance with MOH and DOH requirements, and submit monthly reports.
• Address customer complaints and review expired/near expiry item reports, ensuring proper handling and updates in Oracle.

• Build and maintain effective relationships with MOH personnel and regulatory authorities.
• Facilitate successful product launches through ongoing communication with regulatory bodies.
• Conduct regular visits and calls to relevant stakeholders.

• Bachelor's or master's degree in pharmacy.
• Certification in Supply Chain Management, Quality Assurance, or Lean Six Sigma is desirable.

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