Description
Job Summary:

Performs microbiological testing of raw materials, intermediate/finished products, and environmental bio-burden. Independence, leadership, and technical skills are required to maintain a functional, current and GMP compliant microbiology laboratory. Responsible for continually evaluating the laboratory systems to ensure quality and efficiency. Expected to effect policy with suggestions for improvements. Must be able to handle assignments independently and work with little or no supervision.

Job Responsibilities

• Perform Microbial Limits and Microbial Limits Validation assay of finished products, raw materials, and components.

• Perform bio-burden monitoring of the manufacturing facility and the microbiology laboratory.

• Review the current USP and the regulatory guidance to ensure compliance with updates to microbiological methods.

• Maintain currency with microbiology practices and policies in the pharmaceutical industry.

• Oversee the and maintenance of the USP Purified Water System.

• Author and review microbiology protocols and reports.





• Author, review, and revise microbiology STP's and SOP's.

• Train backup analysts for microbiology tasks in his/her absence.

• Ensure coverage of microbiology assays with back-up analyst for weekend and holiday testing schedules.

• Evaluate trend analysis of microbiology results from tested products, water and bio-burden and author reports.

• Coordinate microbiology testing to complete deliverables in a timely manner.

• Perform IQ/OQPQ on instruments and author the protocols/reports.

• Attend seminars on special topics to continually evaluate improvements to the microbiology laboratory, testing , and policy.

• Act as the microbiology expert for audits and consultations, as required.

• General procurement assignments and responsibilities for the microbiology laboratory: monitor housekeeping, bio hazard waste disposal, sample discard, discard of expired reagents, media preparation, steril

📌 Sr Microbiologist (Kukatpally)
🏢 Aveva Drug Delivery Systems
📍 Kukatpally