Cairo, Egypt
Are you a detail-obsessed professional with a passion for operational excellence and quality assurance? Jamjoom Pharma is seeking a dynamic Senior Validation Executive to drive precision, compliance, and efficiency in our fast-paced Quality team. This is your chance to make a measurable impact in one of the region’s leading pharmaceutical companies.
Key Responsibilities:
Ensure all validation activities comply fully with current Good Manufacturing Practices (cGMP).
Prepare the Validation Master Plan and maintain the full validation lifecycle.
Collaborate cross-functionally with Manufacturing, Quality Control, Engineering, and Regulatory Affairs.
Support regulatory inspections and internal audits as a subject matter expert.
Prepare and execute Aseptic Process Simulation (APS) protocols and reports.
Develop and implement Cleaning Validation protocols aligned with global standards.
Author and execute validation protocols (IQ/OQ/PQ) for equipment, APS, utilities, manufacturing processes, and cleaning procedures.
Lead and manage smaller validation projects from initiation to completion.
Analyze validation data, identify discrepancies, and author comprehensive summary reports.
Investigate and resolve validation deviations and non-conformances.
Collect, review, and verify complete documentation for validation processes.
Prepare Process Validation files for export markets, including CTD and eCTD formats.
Lead Performance Qualification (PQ) for machines, utilities, and production equipment.
Prepare Computerized System Validation (CSV) protocols and reports to support data integrity and system compliance.
Drive validation strategy in collaboration with QA, Production, Engineering, and RA teams.
What We’re Looking For
Proven experience in pharmaceutical validation.
Strong knowledge of international regulatory frameworks (ICH, WHO, FDA, EMA, GMP).
Detail-oriented, organized, and proactive leadership style.
Excellent documentation, communication, and analytical skills.
Strong problem-solving abilities and a collaborative team spirit.
Qualifications & Experience
Bachelor’s degree in Pharmacy.
Minimum 8+ years of hands-on experience in Validation and Qualification within the pharmaceutical industry.
Proven experience preparing CTD/eCTD dossiers for international markets.
Hands-on execution of validation protocols including Equipment Qualification, CSV, Media Fill, Cleaning Validation, and Utilities Qualification.
Deep understanding of cGMP, FDA 21 CFR Part 211, EU Annex 15, and other relevant guidelines.
Ability to manage multiple priorities in a dynamic environment.