Full Time
AUG Pharma -
Egypt , Giza
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AUG Pharma

Job Details

  • Key Responsibilities
  • Validation Management & Execution 
  • Develop and implement the Validation Master Plan (VMP).
  • Manage and supervise all validation activities including:
  • Equipment Qualification (IQ, OQ, PQ)
  • Process Validation
  • Cleaning Validation
  • Computerized 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.

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About AUG Pharma
Egypt, Giza