Key ResponsibilitiesValidation Management & Execution Develop and implement the Validation Master Plan (VMP).Manage and supervise all validation activities including:Equipment Qualification (IQ, OQ, PQ)Process ValidationCleaning ValidationComputerized Systems Validation (CSV)Utility Validation (HVAC, Water System, Compressed Air)Ensure validation activities comply with GMP, EDA, FDA, and EU guidelines.Team Leadership Supervise and guide validation team members.Assign validation tasks and monitor performance.Provide technical support and training to the validation team.Documentation & Compliance Review and approve validation protocols, reports, and related documents.Ensure all validation documentation is accurate, complete, and audit-ready.Maintain validation records according to regulatory and company requirements.Regulatory & Audit Support Participate in internal and external audits and regulatory inspections.Respond to audit observations related to validation activities.Ensure compliance with regulatory authorities such as EDA, FDA, and EMA.Risk Management & Continuous Improvement Perform risk assessments related to validation activities.Identify validation gaps and implement corrective and preventive actions (CAPA).Ensure continuous monitoring to maintain validated state.Cross-Functional Coordination Coordinate with Production, Engineering, Quality Control, and IT departments.Support new equipment qualification and new product introduction.Ensure validation support for change control activities. QualificationsEducation Bachelor’s degree in Pharmacy, Engineering, Biotechnology, or related field. Experience: 5-10 years of experience in quality assurance and validation within a regulated industry. At least 2–3 years in a supervisory or leadership role. Technical Skills Strong knowledge of GMP, Validation lifecycle, and regulatory requirements.Experience with equipment, process, cleaning, and utility validation.Knowledge of EDA, FDA, EU GMP guidelines.Strong documentation and technical writing skills.Skills:Quality AssuranceValidationData ValidationProcess ValidationQuality AuditingQuality AnalysisRoot Cause AnalysisCAPAKnowledge of Giza regulationsPharmaceutical ValidationISO 9001 proficiencyStatistical Analysis skillsRisk Management expertiseLeadership: Demonstrated ability to lead and motivate a team of validation professionals.Communication: Excellent written and verbal communication skills.