Validation Lab Specialist

About the role

The Validation Lab Specialist will perform and review all validation laboratory activities, including test method validation, process validation analysis, and cleaning validation analysis, ensuring compliance with global guidelines and quality standards. The role is based at the factory in El Obour City and reports to the QC Lab Manager.

Key responsibilities

• Perform and review analytical chemical and physical testing related to validation activities, including method validation, process validation samples, and cleaning validation samples.
• Generate, review, and maintain analytical method and cleaning validation documentation, such as protocols, reports, SOPs, and work instructions.
• Participate in root cause investigations of finished product failures.
• Verify and align chemical analysis methods from R&D with ICH guidelines and pharmacopoeias before implementation.
• Maintain and control documentation for validation laboratory instruments, including logbooks, calibration records, reagents, reference standards, and qualification documents, and perform daily equipment calibrations.

Required profile

• Bachelor’s degree in Pharmacy or Chemistry.
• Minimum of 2 years of relevant experience in a similar industry, with hands‑on use of HPLC.
• Strong analytical skills and attention to detail.
• Excellent written and spoken English.

Required skills

• High‑Performance Liquid Chromatography (HPLC) operation and troubleshooting.
• Analytical method validation techniques for chemical and physical testing.