Microbiologist

Kesar Drugs Pvt Ltd

1. Microbial Testing and Quality Control

Test raw materials, intermediate products, and finished pharmaceutical products for microbial contamination.

Perform sterility testing to ensure that products, especially sterile ones like injections, are free from harmful microorganisms.

Conduct bioburden testing to measure the microbial load in non-sterile products.

Test products for endotoxins to ensure they meet safety standards.

2. Environmental Monitoring

Monitor cleanroom environments and production areas for microbial contamination.

Collect air, surface, and personnel samples from manufacturing areas to ensure the cleanliness of the production environment.

Ensure that manufacturing and storage areas comply with Good Manufacturing Practices (GMP) and regulations.

3. Microbial Identification and Characterization

Identify and characterize microorganisms that may be present in pharmaceutical products using microbiological techniques (., culture, PCR, biochemical tests).

Investigate any microbial incidents, such as contamination during the manufacturing process, and take corrective actions.

4. Product Development and Support

Work closely with the R&D (Research and Development) team to ensure the microbiological stability of drug formulations.

Participate in stability testing to ensure the shelf-life and microbial safety of pharmaceutical products over time.

5. Regulatory Compliance

Ensure that the company complies with local and international regulations like FDA (Food and Drug Administration), EMA (European Medicines Agency), and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) regarding microbiological safety.

Prepare documentation for regulatory submissions, ensuring proper microbiological testing data is provided.

6. Validation and Calibration

Validate microbiological methods used in testing and analysis.

Calibrate and maintain laboratory equipment to ensure accuracy and reliability in microbial testing.

• Experience

  0 - 1 Years

• No. of Openings

  2

• Education

  B.Pharma

• Role

  Microbiologist

• Industry Type

  Hospitals / Medical / Healthcare Equipments

• Gender

  Male

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office