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....