Officer, QA Environment Monitoring

Amneal; Sanand; Vor Ort; INR 500.000 - 800.000; Vollzeit

Zusammenfassung

Amneal in Gujarat is seeking a qualified Professional to monitor environmental conditions in sterile manufacturing. You will review trends, coordinate resources, and maintain asset records for EM materials.

You will participate in media fill simulations and area qualification activities, ensuring compliance with regulatory standards and good documentation practices.

Qualifikationen

• Education: B.Sc./ M.Sc in Microbiology.
• Total Experience: 3-5 years in Environmental Monitoring for sterile manufacturing.
• Internal candidates must have completed at least 2 years in current role.

Aufgaben

• Review environment monitoring trends and ensure compliance.
• Procure EM monitoring materials from microbiology lab and hand over after use with required formats.
• Maintain issuance/reconciliation records for EM materials.
• Conduct environmental monitoring in clean rooms as per schedule.
• Participate in media fill simulation studies.
• Participate in qualification activities of manufacturing areas.

Kenntnisse

Environmental Monitoring

Aseptic Process Simulation

GDP

Regulatory & Compliance Knowledge

Ausbildung

B.Sc./ M.Sc in Microbiology

Jobbeschreibung

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.