Senior Officer, QA Environment Monitoring

Amneal; Gujarat; On-site; INR 500,000 - 800,000; Full time

Job summary

Amneal in Gujarat, India seeks a disciplined Practitioner to join our manufacturing operations. You will perform line clearance before dispensing and packaging, conduct environment monitoring, and support batch sampling per SOPs.

The role involves reviewing batch records, qualification activities, and maintaining GMP compliance on the shop floor. Strong attention to detail and knowledge of regulatory requirements are essential for success in this position at Amneal.

Qualifications

• Line clearance and batch record review experience is required.
• Regulatory and compliance knowledge is required.

Responsibilities

• Perform line clearance activities before dispensing, manufacturing, filling, inspection, sealing, labeling, and packing.
• Conduct environment monitoring activities.
• Execute process validation, cleaning validation/verification, hold time studies, media fills, and routine batch sampling per protocol/SOP.
• Perform in-process testing at various stages according to batch documents/SOP.
• Review environment monitoring and water trend data.
• Review planner and calibration certificates.
• Monitor cGMP compliance on the shop floor.
• Review printouts for CIP, SIP, autoclave, filter integrity, etc.
• Maintain issuance/reconciliation records for environment monitoring materials.
• Conduct environmental monitoring of manufacturing clean-room areas per schedule.
• Participate in media-fill simulation studies.
• Perform qualification activities for manufacturing areas.
• Conduct non-viable particle monitoring of clean-room areas per schedule.
• Monitor compressed air/nitrogen gas and personnel.
• Review media-fill CD and visual inspector qualification records.

Skills

Line clearance

Regulatory knowledge

Job description

ROLE

• – Perform line clearance activities before operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing.
• – Conduct environment monitoring activities.
• – Execute process validation, cleaning validation/verification, hold time studies, media fills, and routine batch sampling per protocol/SOP.
• – Perform in‑process testing at various stages according to batch documents/SOP.
• – Review environment monitoring and water trend data.
• – Review planner and calibration certificates.
• – Monitor cGMP compliance on the shop floor.
• – Review printouts for CIP, SIP, autoclave, filter integrity, etc.
• – Maintain issuance/reconciliation records for environment monitoring materials.
• – Conduct environmental monitoring of manufacturing clean‑room areas per schedule.
• – Participate in media‑fill simulation studies.
• – Perform qualification activities for manufacturing areas.
• – Conduct non‑viable particle monitoring of clean‑room areas per schedule.
• – Monitor compressed air/nitrogen gas and personnel.
• – Review media‑fill CD and visual inspector qualification records.

REQUIREMENTS

• – Line Clearance & Batch Record Review – Practitioner
• – Regulatory & Compliance Knowledge – Practitioner