Experience: 3-5 years
No of position: 01
- To perform designated analysis for all In-process, Drug substance, Drug product (release and stability) related samples with necessary documentation and defined level of compliance
- To prepare SOP, STP, Specifications and other quality related documents
- To perform all activities pertaining to cell line maintenance
- To participate in preparation and characterization of cell banks (MCB and WCB)
- To participate in self-inspection and external inspection
- To execute all activities related to Analytical Method Validation e.g. protocol preparation, analysis and report preparation
- To ensure proper operation, cleaning and preventive maintenance (if applicable) of equipment related to cell culture section and concurrent recording of all activities in the respective log books.
- To execute the assigned responsibilities such as equipment monitoring, verification/calibration, Newtronics on regular basis.
- To attend all GMP, QC and QA SOP related training programs.
- To abide by the EHS procedures while performing analysis or any other related activities
- To participate in handling of change controls and investigation in the occurrence of any deviation, OOS with proper CAPA
- To ensure proper inventory of consumables to be used in cell culture section
- To execute any other work allotted by the supervisor on a timely basis
- Should be able to work in shifts
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