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Senior Executive - QC Micro

Amneal Pharmaceuticals • Full-time • Ahmedabad, IN • 1w ago

Job Responsibilities

JOB DESCRIPTION

To handle and distribute various samples received for microbiological analysis.
To maintain the logbook for the same.
Maintain housekeeping of Microbiology lab.
To maintain the inventory of various microbiological media, maintain log and status labels, media preparation, growth promotion test and reconciliation of media.
Microbial culture handling and inoculum preparation.
Water sampling and analysis of water samples as per schedule, with completion of all reports and records. Responsible for Sterility testing, Bacterial endotoxin testing, antibiotic microbial assay and bio burden testing of Raw material, in-process, finished products.
Environmental monitoring of microbiology lab clean room area as per the defined schedule.
Non-viable particle monitoring of microbiology lab clean room area as per the defined schedule.
Responsible to identify and maintain data logging of EM Isolates.
To perform disinfectant efficacy testing as per SOP.
To perform microbial identification as per defined schedule.
Responsible for handling and testing of biological indicator.
To perform CCIT test of post media fill units.
To perform observation of microbial plates exposed in manufacturing area.
To perform media fill unit observation as per SOP.
Responsible for reporting any OOS, Deviation to In-charge.
Responsible for preparation of standard operating procedures of microbiology department.
Responsible to co-ordinate with manufacturing, Engineering, and other QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
Responsible to participate in perform qualification activities of manufacturing and Microbiology area.
Responsible for Compressed air /nitrogen gas monitoring and Personnel monitoring.
Preparation of indents as per the materials/product requirements.
To initiate and review of a) Change controls b) Out of specifications c) Deviations.
To attain and complete self- training record.
Preparation of study protocols with respect to laboratory.
Review of instruments logbooks, raw data of raw materials, packing materials, miscellaneous materials, in-process, finished products and water analysis.
Preparation of COA.
To keep neat and cleanliness at workplace and follow the good laboratory practices and safety related instruction in the laboratory.
To perform water analysis and maintain daily water trend.
Sampling, testing and release of Raw material, packing material, miscellaneous material samples and in process sample and maintain reserve sample as per SOP.