Chief Cleanliness Officer

7 days ago

Ellore, Andhra Pradesh, India beBeeMicrobiologist Full time ₹ 8,00,000 - ₹ 12,12,000

As a microbe specialist at Alp Consulting Ltd, you will play a crucial role in ensuring the quality and safety of our products. Your primary responsibility will be to monitor environmental conditions for microbes to maintain cleanliness.

Key Responsibilities:

  • Perform microbial limit tests, BET, sterility testing, and other microbiological analyses on water, APIs, and KSMs.
  • Support cleaning validation by conducting swab/rinse microbiological analysis and preparing reports.
  • Conduct microbiological validation studies, including filter integrity testing and media fills for clean processes.
  • Participate in qualification of controlled areas, equipment, and utilities.
  • Prepare and review Standard Operating Procedures (SOPs), protocols, and reports.
  • Maintain accurate microbiological records and participate in regulatory inspections and customer audits.
  • Investigate out-of-specification (OOS) or out-of-trend (OOT) results related to microbial data.
  • Conduct microbiological risk assessments and propose corrective actions.
  • Stay updated with pharmacopeia changes, ICH guidelines, and regulatory expectations.

Requirements:

  • Bachelor's/Master's degree in Microbiology, Biotechnology, or Life Sciences.
  • 2-4 years of experience in the API/Pharmaceutical industry.

Benefits:

  • Challenging work environment
  • Opportunities for growth and development

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