Executive QA Environment Monitoring

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 600,000 - 1,100,000; Full time

Job summary

Amneal Pharmaceuticals LLC seeks an Environmental Monitoring specialist with 1–6 years of experience in EM for sterile manufacturing. Candidates should hold a B.Sc./M.Sc in Microbiology and possess expertise in EM, media fill monitoring, GDP practices, and regulatory compliance.

Internal candidates require at least 2 years in the current role. The role involves reviewing EM trends, ensuring resource availability, and participating in media fill simulations and area qualifications within the

Qualifications

• Experience in environmental monitoring for sterile manufacturing is required.
• Expert in EM and media fill monitoring.
• Strong GDP understanding and regulatory/compliance knowledge.
• Internal candidates require at least 2 years in current role.

Responsibilities

• Review EM trends and ensure monitoring supplies are available and aseptically handled.
• Maintain issuance/reconciliation records for EM materials.
• Conduct environmental monitoring of clean rooms per schedule.
• Participate in media fill simulation studies and area qualification activities.
• Perform non-viable particle monitoring and related checks.
• Oversee compressed air/nitrogen gas monitoring and personnel monitoring.
• Review Media Fill CD as part of quality assurance.

Skills

Environmental Monitoring

Media Fill Monitoring

GDP

Regulatory Knowledge

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.

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.

Requirements: