This position is responsible for qualification and manufacturing activities in the Drug Substance manufacturing facilities and will assist the installation and commissioning activities of the process equipment’s, facility in the Appasamy Associates Pvt Ltd.
This position is responsible for the preparation of cGMP documents like SOPs, BMR, Protocol and etc, related to the Process Equipments, Manufacturing process which are undergoing commissioning and will assist in the validation of the equipment in Appasamy Associates Pvt Ltd.
This position will be part of all routine manufacturing operations of Downstream activities with relevant cGMP requirements.
Responsible for following and adhering cGMP compliance policies at Appasamy Associates Pvt Ltd and all activities in Drug substance manufacturing.
Responsible for executing the day-to-day activities in downstream activities.
Executing the SAT, IQ, OQ and PQ of equipment’s in DS manufacturing Area.
Execution of commercial manufacturing process of drug substances.
To ensure that batches are carried out as per the shifts and instructions following relevant SOP’s and to ensure appropriate documentation in order to maintain cGMP compliance.
To coordinate and complete the activities related to facility to ensure smooth functioning of the production activities.
To ensure the upkeep of the facility for running the process and related process.
To involve in the discussions and execution of Downstream processing of other products with proper training.
To coordinate with Engineering, QA, QC and WH for smooth functioning of the production.
Preparation of quality documents like SOP’s, BMR and MFR etc.
Handling of change control, deviation, carrying out batch failure investigation.
Shall be responsible for the safety rules and practices in the company premises and shall identify the unsafe conditions and their risk mitigation.
Responsible for safety of self and other colleagues in all aspects.
Support the department with Administrati