Senior Executive - QC Micro

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. To keep update of instruments logbooks and to record the data in Laboratory Notebook / and respective software. To monitor and plan the activities of various glassware and items required for microbiological analysis with respect to their cleaning, sterilization, and dehydrogenation. To maintain log and status labels for all such items and reconciliation record. Responsible for Pure culture handling and maintenance. To maintain daily logs of area with respect to temperature, humidity, differential pressure, area cleaning, disinfectant preparation, etc.. Responsible to review the environment monitoring, water trends. Responsible to receive the required resources for EM monitoring e.g., plates, samplers, swabs etc.. from microbiology lab and after completion of EM monitoring plates, samplers, swabs etc.. should be handed over to microbiology lab for further process along with applicable formats which is filled in aseptic area. To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g., plates, swabs, etc.. Environmental monitoring of manufacturing clean room area as per the defined schedule. Responsible to participate in media fill simulation study. Non-viable particle monitoring of manufacturing clean room area as per the defined schedule. Compressed air /nitrogen gas monitoring and Personnel monitoring. Review of Media fill CD. Skill:

Inspection, EM and Testing of Injectable Products

Qualification - B.Sc. /M.Sc.