Executive, QA Environment Monitoring

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Gujarat is seeking an Environmental Monitoring professional to review trends and manage resources for EM monitoring in a sterile manufacturing setting.

You will handle aseptic process simulations (media fill), participate in qualification activities, perform non-viable particle monitoring, and ensure GDP and regulatory compliance in daily operations, with emphasis on documentation quality.

Qualifications

• EM monitoring experience in sterile manufacturing.
• Aseptic process simulation and media fill experience.
• Good documentation practices and regulatory knowledge.

Responsibilities

• Review environment monitoring trends and manage EM resources.
• Maintain issuance/reconciliation records for EM materials.
• Conduct environmental monitoring of clean room areas per schedule.
• Participate in media fill simulations and qualification activities.
• Perform non-viable particle monitoring and monitor compressed air/nitrogen.

Skills

Environmental Monitoring (EM) - Expert

Aseptic Process Simulation (Media Fill

Good Documentation Practices (GDP) - 0

Regulatory & Compliance Knowledge - 0

Education

B.Sc./ M.Sc in Microbiology

Job description

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.

• 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.