Validation Manager

Job ScopeThe Validation Manager is responsible for managing, developing, and maintaining all validation activities within the company in accordance with GMP rules and through the implementation of an effective quality system. The role ensures that equipment, utilities, facilities, and processes are validated and compliant with regulatory requirements, while supporting continuous improvement and operational excellence.Job Requirements Education: B.Sc. degree in Pharmacy, Chemical Engineering, Biology, Chemistry, or any related scientific field. Experience: Minimum of 12 years of experience in the pharmaceutical industry, Languages: Proficiency in written and spoken Arabic; fluency in French and English is a plus.Professional Knowledge Deep understanding of ICH, GMP, GLP, and WHO systems. Knowledge of production area layout design, material/process/people flow. Proficiency in statistical analysis, risk-based validation approaches, and quality tools. Strong knowledge of documentation control and good documentation practices. Experience with failure investigations and change control systems.Main Competencies Strong decision-making and analytical skills. Expertise in management processes and financial awareness. Leadership and coaching abilities. Strategic thinking and continuous improvement mindset.Duties And Responsibilities Develop and manage the company’s validation strategy in alignment with regulatory requirements and company objectives. Approve all validation-related documents including master plans, protocols, and reports. Ensure that all equipment, systems, and processes are validated, calibrated, and documented according to GMP. Participate in the design and qualification of facilities, utilities, and equipment. Conduct investigations into validation-related failures and ensure corrective actions are implemented. Ensure periodic revalidation and continuous compliance of existing systems. Monitor adherence to GMP and other regulatory requirements. Oversee department performance, training, and manpower planning. Support regulatory audits and inspections. Develop, maintain, and implement the Validation Master Plan (VMP) in alignment with GMP, regulatory requirements, and company strategy. Define validation policies, methodology, and lifecycle management for processes, equipment, utilities, cleaning, and computerized systems. Plan validation activities to support production readiness, new projects, and regulatory expectations. Lead the process validation lifecycle (Stage 1–3) according to FDA, EMA, WHO, and ICH (e.g., ICH Q8, Q9, Q10, Q11). Approve validation protocols and reports (PPQ – Process Performance Qualification). Ensure continued process verification (CPV) and trending of critical parameters. Ensure manufacturing processes remain validated and in a state of control. Define the cleaning validation strategy and establish MACO/ PDE limits for residues. Approve cleaning validation/verification protocols and reports. Ensure control of cross-contamination and alignment with Annex 1 and Annex 15 requirements. Supervise and approve qualification activities for equipment, HVAC, water systems (PW/WFI), clean utilities, and manufacturing facilities. Oversee DQ, FAT, SAT, IQ, OQ, PQ in compliance with GMP and Annex 15. Ensure periodic qualification and requalification programs are defined and respected. Develop risk-based C&Q approaches (e.g., ASTM E2500). Ensure adequate engineering documentation, traceability, and qualification evidence before release to production. Ensure GxP computerized systems are validated and in compliance with 21 CFR Part 11, Annex 11, and Data Integrity (ALCOA+). Coordinate validation activities with Production, QC, QA, Engineering, and HSE. Provide validation support during tech transfer, new product introduction, and equipment upgrades. Manage timelines and resource planning for validation projects. Implement best practices, engineering improvements, and digital tools (e.g., e-logs, e-validation systems). Drive continuous improvement to reduce validation time, improve robustness, and enhance compliance. Monitor KPIs (e.g., validation schedule adherence, deviations during PPQ, requalification status).