In charge of Microbiology department

4 days ago

Pune, Maharashtra, India Inducare Pharma Private Limited Full time ₹ 24,00,000 - ₹ 72,00,000 per year

Designation - In charge of Microbiology Department

Industry - Pharmaceutical

Experience - 5+ Years

FDA Approval Micrologist

Job Summary:

Roles And Responsibilities-

The Microbiologist is responsible for performing microbiological testing of raw materials, in-process samples, finished products, and environmental samples to ensure compliance with GMP and regulatory standards.

Key Responsibilities:

  • Perform microbiological analysis of raw materials, in-process samples, and finished products.
  • Conduct environmental monitoring of production and microbiology areas (air, surface, personnel monitoring, etc.).
  • Perform tests such as Sterility Testing, Endotoxin Testing (LAL test), Microbial Limit Test (MLT), and Water Testing (RO, Purified, WFI).
  • Prepare and maintain culture media, reagents, and microbial cultures.
  • Identify and maintain microbial cultures used in routine analysis.
  • Calibrate and maintain microbiology laboratory instruments (autoclave, incubator, laminar air flow, etc.).
  • Maintain proper documentation as per GMP guidelines (records, logbooks, and data sheets).
  • Participate in validation activities (media fill, cleaning validation, environmental validation).
  • Ensure adherence to safety and aseptic practices in the microbiology lab.

Report out-of-specification (OOS) and deviations to the QC Head and participate in investigations.

M.Sc. in Science, with Micrology

Background in manufacturing and analytical techniques

5 + years relevant experience in the regulated pharmaceutical industry, specifically including Quality Control Microbiology Lab

Experience with Health Canada GMP inspections and third-party audits

FDA Approval Certificate

  • Skills Required:
  • Knowledge of cGMP and GLP practices.
  • Familiarity with regulatory requirements (FDA, WHO, GMP).
  • Strong analytical and documentation skills.
  • Attention to detail and adherence to lab safety protocols.

Job Type: Full-time

Pay: ₹40, ₹60,000.00 per month

Benefits:

  • Health insurance
  • Provident Fund

Ability to commute/relocate:

  • Pune, Maharashtra: Reliably commute or planning to relocate before starting work (Required)

Education:

  • Master's (Preferred)

Experience:

  • total work: 5 years (Preferred)
  • Microbiology: 5 years (Required)
  • Pharmaceutical: 3 years (Required)

License/Certification:

  • FDA Approval Microbiologist (Preferred)

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