Validation Supervisor

Job Summary:

To Supervise and ensure that validation, qualification and calibration activities at EL KENDI are carried out to a common standard and are in compliance with the requirements of GMPs.

Main Duties:

· Supervise and coordinate cleaning validation, qualification, and calibration processes.

· Prepare comprehensive validation documentation, including master plans, protocols, reports, SOPs, and related materials.

· Review, amend, and close validation protocols to ensure compliance and accuracy.

· Maintain up-to-date records of validation activities, monitoring dashboards, and QMex Modules.

· Establish and manage a robust system for archiving validation documentation in coordination with quality assurance.

· Contribute to annual product quality reviews, summarizing key findings and recommendations.

· Provide training on validation systems and SOPs to relevant personnel.

· Participate in internal audits and inspections, addressing any identified observations..

Requirements :

· Certification: B.Sc. degree or M.sc in Pharmacy, chemistry, Chemical Engineering, other related science requested

· Experience: Minimum Three years in pharmaceutical industry.

· Language: Proficiency in both written and spoken Arabic, French.

Technical Knowledge:

· Knowledge in documentation control systems

· Knowledge in the systems such as GMP, ICH, GLP, WHO

· Knowledge in validation regulations upgrades.

· Knowledge in Process, design, installation, operation, manufacturing machines, utilities

· ISO standards relevant.

· Knowledge in cleaning validation.

· Knowledge in internal system SOP’s and guidance’s.

· Knowledge in basic statistic and quality tools.

Behavioral Skills:

· Initiative

· Ability to perform the job accurately

· Flexibility & adaptability to work with team and relevant to different tasks

· Integrity & Transparency

· Ability to handle multiple interrelated tasks and in complex timeframes while maintaining the quality of work

· Team Management