Job Description

Job Location: Bangalore
Department Details
Generic Formulation Injectable QCM
Role Summary
Quality Control Microbiology - Reviewer cum Analyst
Key Responsibilities

• Water sampling and analysis (purified water, water for injection and pure steam).
• To perform MLT, Bioburden, BET and sterility analysis.
• Media preparation, qualification of the reagents and media.
• Container closure integrity test.
• Perform Disinfectant efficacy test.
• Analysis of cleaning validation samples (Swab/Rinse).
• Perform area, utility and equipment qualification/calibration.
• Shall follow, Good manufacturing practices Good microbiology practices and Good documentation practices.
• To perform any other activities assigned by the HOD/designee.
• Review of Instrument/ equipment calibration, preventive maintenance and performance qualifications.
• To perform/review the microbiological analysis of different types of water, review of trends and summary reports.
• To review environment monitoring reports, trends and summary reports.
• Review of cleaning validation/process validation protocols and reports in coordination with QA.
• Planning of raw material sampling.
• Planning and timely release and review of RM/FP/Stability test.
• To perform/review enumeration tests and tests for specified organisms as per method validation document or standard testing procedure.
• Planning for the arrangement of preparation of media/ reagents and Review of related records.
• Issue of test reports of raw material, finished products and water.
• Validation protocols and reports, method validation protocols and reports, analysis of data obtained from various test parameters.
• Responsible for investigation/review of incidents/deviation related to microbiology.
• Responsible for preparation/review of Incident trends.
• Responsible for initiation/investigation/review of change control/CAPA/Deviation/OOS/OOT as applicable.
• Adhere to the data integrity policy of the company.

Qualification & Experience
Qualification: MSc (Microbiology)
Experience: 8 to 10 Years

Skills Required