Senior Validation Executive Jamjoom Pharma  

Employer Active

Posted 10 hrs ago

Experience

8 - 13 Years

Job Location

Cairo - Egypt

Education

Any Graduation()

Nationality

Any Nationality

Gender

Not Mentioned

Vacancy

1 Vacancy

Job Description

Roles & Responsibilities

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.

Desired Candidate Profile

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.

Company Industry

Department / Functional Area

Keywords

  • Senior Validation Executive

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