Officer, QA Environment Monitoring

Amneal Pharmaceuticals LLC; Ahmedabad District; Sur place; INR 600 000 - 900 000; Plein temps

Résumé du poste

Amneal Pharmaceuticals LLC seeks a specialist to review environment monitoring trends in a sterile manufacturing setting. You will receive EM resources from the microbiology lab and hand over completed materials with proper aseptic documentation.

Responsibilities include maintaining issuance records, conducting scheduled environmental monitoring of clean rooms, participating in media fill simulations and qualification activities, and performing non-viable particle monitoring and gas monitoring

Qualifications

• EM monitoring expertise in sterile manufacturing.
• Experience with aseptic processes and media fill monitoring.
• Knowledge of Good Documentation Practices and regulatory compliance.
• Understanding of regulatory expectations for clean room environments.

Responsabilités

• Review environment monitoring trends.
• Acquire resources for EM monitoring (plates, samplers, swabs) from microbiology lab.
• Handover completed EM materials to microbiology with required formats.
• Maintain issuance/reconciliation records for EM materials.
• Conduct environmental monitoring of manufacturing clean rooms as scheduled.
• Participate in media fill simulation studies.
• Participate in qualification activities for manufacturing areas.
• Perform non-viable particle monitoring as per schedule.
• Monitor compressed air and nitrogen gas and perform personnel monitoring.
• Review Media Fill CD.

Connaissances

EM monitoring

Media Fill

GDP

Regulatory knowledge

Formation

B.Sc./ M.Sc in Microbiology

Description du poste

• 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.

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 - 3 - 5 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.