QCM analyst

• Responsible for Sample receipt of raw materials, in process, finished product and stability samples.
• Responsible for Microbiological analysis, Sterility testing, Bacterial Endotoxin Test and analysis of different grades of water (PW/WFI/POW) as per the respective specification.
• Responsible for risk assessment documents preparations, Protocol and reports preparation
• Responsible for QMS related to microbiology – change controls, CAPA, deviations, incidents, OOS/OOT investigations
• Responsible for Area qualification, calibrations, equipment qualifications and requalification
• Responsible for sample management and coordination with team for smooth operation of samples release activity.
• Responsible to perform the Bioburden and Microbial Limit Test.
• Responsible to perform the Method verification activity for Sterility, BET, MLT and Bioburden test.
• Responsible for environmental monitoring of clean rooms in Microbiology laboratory.
• Responsible for all microbiological related activities like Media receipt, Media stock maintenance, Preparation of media, Sterilization, Growth Promotion for media, Culture maintenance and Media Disposal.
• Responsible for review of microbiology documents
• Follow the required EHSS policies and Good hygiene practice.

Undertake other responsibilities related to Microbiology as per requirement.