Executive, QA Environment Monitoring

Amneal; Gujarat; On-site; INR 600,000 - 900,000; Full time

Job summary

Amneal in India is seeking a Regulatory & Compliance Practitioner to support environmental monitoring activities in manufacturing operations. You will review environment monitoring trends, maintain issuance and reconciliation records, and participate in media fill simulations and qualification activities.

You will monitor clean room environments, non-viable particle testing, and process gases, ensuring adherence to defined schedules and regulatory requirements.

Qualifications

• Regulatory & Compliance Knowledge – Practitioner.

Responsibilities

• Review environment monitoring trends.
• Maintain issuance/reconciliation record of items/media for environment monitoring material.
• Perform environmental monitoring of manufacturing clean room area as per the defined schedule.
• Participate in media fill simulation study.
• Participate in qualification activities of manufacturing area.
• Conduct non-viable particle monitoring of manufacturing clean room area as per the defined schedule.
• Monitor compressed air/nitrogen gas and personnel.
• Review Media fill CD.

Skills

Regulatory & Compliance Knowledge

Job description

ROLE

• – Review environment monitoring trends.
• – Maintain issuance/reconciliation record of items/media for environment monitoring material.
• – Perform environmental monitoring of manufacturing clean room area as per the defined schedule.
• – Participate in media fill simulation study.
• – Participate in qualification activities of manufacturing area.
• – Conduct non-viable particle monitoring of manufacturing clean room area as per the defined schedule.
• – Monitor compressed air/nitrogen gas and personnel.
• – Review Media fill CD.

REQUIREMENTS

• – Regulatory & Compliance Knowledge – Practitioner