Senior Officer, QC Testing

• Maintain media stock and reconcile records of media used in analysis.
• Perform water sampling and analysis following defined SOPs/protocols and ensure proper documentation.
• Report and log OOS (Out of Specification), OOT (Out of Trend), and EM (Environmental Monitoring) excursions.
• Conduct environmental monitoring of the laboratory.
• Perform analytical validation, culture maintenance, and growth promotion testing (GPT) of media; record observations and generate reports.
• Carry out microbiology laboratory tests such as Bioburden Analysis, MLT (Microbial Limit Test), Sterility Testing, BET (Bacterial Endotoxin Test), etc., in compliance with approved procedures.

 

Skills and Proficiency:

• Microbiology Instrumentation Handling – Expert
• Good Laboratory Practices (GLP) & Documentation Accuracy – Practitioner
• Data Integrity & Documentation – Practitioner
• Regulatory Compliance – Practitioner
• SOP Preparation & Revision – Practitioner
• BET & Sterility testing expertise and evaluation skills – Expert
• Interpretation of Resulting Data Trend – Practitioner
• Laboratory Instrument qualification, Calibration & Maintenance – Practitioner
• Quality Control & Compliance – Practitioner
• QMS Documentation (OOS, OOT, Deviation & Incident) – Beginner
• CAPA, Deviation, and Change Control Management – Beginner