Job Description

Key Responsibilities

Environmental Monitoring Program Management

  • Perform and oversee routine environmental monitoring (air, surfaces, personnel) in classified areas.
  • Ensure sampling plans comply with regulatory guidelines (EU GMP Annex 1, FDA, ISO standards).
  • Review and approve monitoring schedules, sampling locations, and risk assessments.

    • Data Analysis & Reporting

  • Analyze environmental monitoring data for trends and deviations.
  • Prepare detailed reports and summaries for internal audits and regulatory inspections.
  • Implement corrective and preventive actions (CAPA) based on data trends.

    • Compliance & Documentation

  • Maintain accurate and complete documentation in accordance with GMP and company SOPs.
  • Support investigations related to environmental excursions and contamination events.
  • Ensure compliance with regulatory requirements during audits and inspections.

    • ...

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