Microbiological Specialist

18 hours ago

Kollam, Kerala, India beBeeMicrobiologist Full time ₹ 8,00,000 - ₹ 12,00,000

Job Title: Microbiological Specialist

Key Responsibilities:

  • Conduct regular environmental monitoring to ensure aseptic conditions, focusing on air, surfaces, and personnel.
  • Sample and test purified water and raw water supplies for microbiological contaminants.
  • Pursue qualification of controlled areas, equipment, and utilities, including HVAC, water systems, and compressed air.
  • Prepare, review, and implement Standard Operating Procedures (SOPs), protocols, and reports for all microbiology-related tasks.
  • Maintain accurate and up-to-date records of microbiological findings in accordance with GMP requirements and data integrity principles.
  • Support regulatory inspections and customer audits by providing detailed information and answering microbiology-related queries.
  • Investigate out-of-specification (OOS) or out-of-trend (OOT) investigations related to microbial results, ensuring prompt resolution and corrective actions.
  • Develop and implement effective contamination control strategies to minimize risk and ensure compliance.
  • Stay informed about the latest pharmacopeia changes, ICH guidelines, and regulatory expectations in the field of microbiology.

Required Qualifications:

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

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