QC Microbiologist

Job Title: QC Microbiologist

Experience: 1 to 3 Years

Role & Responsibility:

The primary responsibilities of a Microbiologist include:

• Sample analysis and reporting for analysis, finished products, validation, stability, equipment Qualification, Calibration, and documentation review for Microbiology.
• Execute tasks in accordance with cGMP guidelines.
• Perform microbiological testing of microbial limit test of batch release and stability as per the approved SOP and STP.
• Interpretation and release of the analyzed microbiology testing to observe the structural characteristics of the microorganisms to identify the gram nature, family, and species of the microorganisms.
• Analyzing samples by performing Microbial Limit Test, Bacterial Endotoxin Test, Preservative Efficacy Test for finished & stability products, and raw material, as per the approved procedures and analysis with appropriate documentation and strict adherence to Good Documentation Practices.
• Perform Environmental Monitoring by Settle Plate and another different method as per the approved procedures and analysis with appropriate documentation and strict adherence to Good Documentation Practices.
• Develop and validate Microbiology methods for the testing of manufactured products to agreed specifications that remain in compliance with current relevant pharmacopeial standards and requirements.
• Perform Growth Promotion Test as per the approved SOP and along with the documentation for the same.
• Provide microbiological expertise during investigations, root cause analysis, change controls, and deviations.
• Initiation and Review of Change control, deviation, complaints, and any QMS records and responsible for closing the QMS actions.
• Perform trend analysis of microbiology test results and investigate any OOT/OOS analytical according to the relevant SOPs.
• Maintain the stock of the microbiological consumables as per the requirements.
• Maintain and clean the microbiology laboratory as per the approved SOP.
• Perform the Qualification, Calibration, maintenance, and Validation for all laboratory instruments.
• Participate in documentation, laboratory systems, and processes to include updating existing ones as required.
• Write reports, SOPs, and other documentation when required.