Executive, QA Environment Monitoring

Amneal; Sanand; On-site; INR 350,000 - 550,000; Full time

Job summary

Amneal is seeking an Environmental Monitoring professional to oversee EM trends, ensure aseptic area compliance, and maintain records for EM materials in our sterile manufacturing plant in India.

The role involves coordinating resource intake for EM, participating in media fill simulations, and conducting non-viable particle monitoring and air gas checks as per schedule, with strict GDP and regulatory alignment.

Qualifications

• Education: B.Sc./ M.Sc in Microbiology.
• Total Experience: 1-6 years in Environmental Monitoring for sterile manufacturing plant.
• Note: Internal candidates must have completed at least 2 years in current role.

Responsibilities

• Review environment monitoring trends.
• Receive resources for EM monitoring (plates, swabs, samplers) and handover after completion.
• Maintain issuance/reconciliation records for EM materials (plates, swabs).
• Monitor environmental conditions in clean room areas per schedule.
• Participate in media fill simulation studies.
• Participate in qualification activities of manufacturing areas.
• Monitor non-viable particles in clean rooms per schedule.
• Monitor compressed air/nitrogen gas and personnel.
• Review Media Fill CD.

Skills

Environmental Monitoring

Aseptic Process Simulation (Media Fill

Education

BSc/MSc Microbiology

Job description

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 - 1 - 6 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.