Environmental Monitoring Specialist

7 days ago

Mumbai, Maharashtra, India beBeeMicrobiology Full time ₹ 9,00,000 - ₹ 12,00,000

Job Title: Microbiologist

We require a skilled Microbiology Professional to perform various tasks related to environmental monitoring, sampling and testing of purified and raw water, microbiological validation studies, and qualification of controlled areas and equipment.

The ideal candidate will possess a strong educational background in Microbiology or a related field and have 2-4 years of experience in the API/Pharmaceutical industry.

Responsibilities:

• Conduct thorough environmental monitoring of classified areas to ensure aseptic conditions are maintained.

• Plan and execute sampling and testing of purified water and raw water, ensuring all protocols are followed.

• Develop and implement microbiological validation studies, including filter integrity testing and media fills for aseptic processes.

• Collaborate with the team to qualify controlled areas, equipment, and utilities (HVAC, water systems, compressed air).

• Create and review Standard Operating Procedures (SOPs), protocols, and reports to ensure compliance with GMP and data integrity requirements.

• Maintain accurate and up-to-date microbiological records, adhering to ALCOA+ principles.

• Support regulatory inspections and customer audits by providing necessary information and responding to microbiology-related queries.

• Identify and resolve issues through root cause analysis and propose corrective and preventive actions (CAPA).

• Stay current with pharmacopeia changes, ICH guidelines, and regulatory expectations to ensure continuous improvement.

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