QCM analyst

Syngene International Limited

0 years

0 Lacs

bengaluru karnataka india

Posted:1 day ago| Platform:

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Skills Required

stability analysis testing test risk assessment reports microbiology controls management coordination verification monitoring maintenance

Work Mode

On-site

Job Type

Full Time

Job Description

Date: 18 Aug 2025
Location:Bangalore, KA, IN, 560099Custom Field 1: Essential Functions

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.

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