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Environmental Monitoring Program Lead Consultant

ProPharma Group

ProPharma Group seeks an experienced consultant to lead a comprehensive assessment of environmental monitoring and contamination control programs for a three-month engagement in Kansas City. The role involves evaluating procedures, investigations, sampling strategies, cleaning practices, and risk assessments within sterile manufacturing environments.

Responsibilities

  • Evaluate existing environmental monitoring procedures and contamination control programs
  • Conduct investigations and trending analysis of EM data and findings
  • Assess cleaning and disinfection practices and effectiveness
  • Review sampling strategies and risk assessments for sterile manufacturing
  • Provide recommendations to optimize monitoring and control protocols

Requirements

  • 10+ years of experience in environmental monitoring and microbiology
  • Demonstrated expertise in contamination control and cleaning/disinfection practices
  • Knowledge of Annex 1 and sterile manufacturing regulations
  • Experience with EM procedures, investigations, and trending analysis
  • Risk assessment development and implementation skills
Vacancy posted 2 days ago
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