Officer, QA Environment Monitoring

Job Description

• Responsible to review the environment monitoring trends.
• Responsible to receive the required resources for EM monitoring e.g., plates, samplers, swabs etc.. from microbiology lab and after completion of EM monitoring plates, samplers, swabs etc.. should be handed over to microbiology lab for further process along with applicable formats which is filled in aseptic area.
• To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g., plates, swabs, etc..
• Environmental monitoring of manufacturing clean room area as per the defined schedule.
• Responsible to participate in media fill simulation study.
• Responsible to participate in perform qualification activities of manufacturing area.
• Non-viable particle monitoring of manufacturing clean room area as per the defined schedule.
• Compressed air /nitrogen gas monitoring and Personnel monitoring.
• Review of Media fill CD.
  
  

Skills

• Environmental Monitoring (EM) - Expert
• Aseptic Process Simulation (Media Fill) Monitoring - Expert
• Good Documentation Practices (GDP) - Practitioner
• Regulatory & Compliance Knowledge - Practitioner
  
  

Qualifications

Education: B.Sc./ M.Sc in Microbiology

Total Experience - 3 - 5 Year inexperience in Environmental Monitoring for sterile manufacturing plant

Note: Candidates who want to apply for internal jobs, must have completed atleast 2 years within existing role.