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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
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- Quality
- Testing
- QA
- QC
- Inspector
Keywords
- Senior Validation Executive
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