Senior Validation & Quality Assurance Leader (Pharma)

Julphar; Ras Al Khaimah; Sur place; AED 300 000 - 420 000; Plein temps

Résumé du poste

Julphar, a leading pharmaceutical company in the United Arab Emirates, seeks a senior Validation and Quality Systems expert to lead equipment and utilities qualification, CSV, calibration, and GMP compliance.

You will oversee cross-functional teams, ensure regulatory alignment (FDA, WHO, EU), maintain EQMS data integrity, and drive continuous improvement and risk management across quality systems.

Qualifications

• Bachelor’s degree in Engineering, Science, or Pharmacy.
• Minimum 10 years of experience in equipment/facilities qualification and validation.
• GMP, GDP, ISO 9001 and ISO 14001 knowledge.
• Familiar with FDA, WHO, EU guidelines and 21 CFR Part 11.

Responsabilités

• Lead qualification lifecycle for equipment, facilities, and utilities (URS to PQ).
• Ensure critical utilities remain qualified (PW, WFI, compressed air, nitrogen).
• Oversee cleanroom qualification per ISO 14644.
• Lead CSV validation for QC, Manufacturing, and Utilities.
• Maintain validated systems and data integrity (ALCOA+).
• Manage Change Controls, Deviation Investigations, CAPA via EQMS.
• Coordinate cross-functional teams and document management.
• Drive continuous improvement and risk management initiatives.
• Ensure GMP and regulatory compliance and support inspections.
• Promote EHS practices per ISO 14001:2015.

Connaissances

Equipment qualification

Facilities qualification

Calibration management

Validation lifecycle

Computerized System Validation

GMP knowledge

GDP knowledge

Regulatory guidelines

Risk management

Leadership

Data integrity

ALCOA+

Formation

Bachelor's degree in Engineering, Science, or Pharmacy

Outils

EQMS

Microsoft Office

GxP systems

Description du poste

Julphar, a leading pharmaceutical company in the United Arab Emirates, seeks a senior Validation and Quality Systems expert to lead equipment and utilities qualification, CSV, calibration, and GMP compliance.

You will oversee cross-functional teams, ensure regulatory alignment (FDA, WHO, EU), maintain EQMS data integrity, and drive continuous improvement and risk management across quality systems.