Execute unit operations within ds/ups as per the bpr ; conducts activities in support of production schedules; obtains and stocks supplies as required and under supervision; prepares media / buffers and solutions as required for the unit operation , perform routine cleaning and support activities in gmp manufacturing areas, including rotuine process area cleaning, autoclave operation, manual cleaning and sterilization of components and parts; monitors processes and results and suggest methods to ensure process success ; interfaces with process automation systems
In order to execute unit operations as per the production specification and yield requirements
Compliance & documentation
Issues discrepancies and work with cross-functional departments to close the discrepancies and implement appropriate corrective actions; comply with all relevant gmp, safety standards and sops of the operation of designated manufacturing equipmentComplete batch documentation in compliance with gmpCollection and maintenance of data in accordance with cgmps, company standards, policies and other regulatory requirements; supports team in effective and timely completion of root cause investigations and capa
In order to ensure effective and efficient production operations across all plants.
Maintaining manufacturing equipment to ensure correct functionality and calibration complianceOperation of manufacturing equipment and automated systems within the validated process parameters ; support qualification and validation activities
In order to ensure that the batch runs on a qualified equipment.
Safety & facility inspection
Actively promote safety awareness and improvements; proactively engage in continuous improvement activities; adhere to the companys safety rules and conduct all work in a manner report all unsafe matters and near miss /accidents.
In order to ensure safe and hazard free production operations.
Skills required: cell culture upstream/microbial fermentation, table top equipment like metabolite analysis, autoclave operations, microscopy.
Posted 30+ days ago