Job Description

Duration: 6-Month Contract

Position Summar

yWe are seeking an experienced MSAT Environmental Monitoring (EM) Expert to support Environmental Monitoring Performance Qualification (EM PQ) activities within a GMP-regulated pharmaceutical manufacturing environment. The successful candidate will act as a Subject Matter Expert (SME) in environmental monitoring, validation, manufacturing processes, and quality compliance

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Key Responsibiliti

  • esLead Environmental Monitoring Performance Qualification (EM PQ) activities and coordinate cross-functional stakeholder
  • s.Develop, execute, and review validation protocols and reports, including process validation, hold-time studies, and extractables studie
  • s.Ensure compliance with GMP, ISO 13485, and 21 CFR Part 820 requirement
  • s.Support risk assessments, investigations, deviations, discrepancy records, and change control
  • s.Lead technical investigations and roo...

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