To maintain the equipments and following with maintenance. To follow the cGMP To follow the safety norms and adhere with company policy Ensure the compliance of SOPs and cGMP during batch operating. Checking the cleanliness of all equipments and areas. Giving feedback to superiors regarding any abnormality, deviation or specific observation, related to process, equipment of facility. Preparation of process /drying/cleaning/blending validation protocols and reports and compliance the requirements. Preparation of Standard operating procedures related to Production activities. Maintain accurate records of production data. Identify and troubleshoot production issues to minimize downtime and maintain productivity. Develop and implement standard operating procedures to ensure consistent and efficient production processes. Participate in cross-functional teams to support new product development and scale-up of production processes
Respnsibilities : To maintain the equipments and following with maintenance. To follow the cGMP To follow the safety norms and adhere with company policy Ensure the compliance of SOPs and cGMP during batch operating. Maintaining the safety equipment and are used by plant personals as and when required and also the availability of accessories required for safety and housekeeping. Checking the cleanliness of all equipments and areas. Giving feedback to superiors regarding any abnormality, deviation or specific observation, related to process, equipment of facility. Preparation of process /drying/cleaning/blending validation protocols and reports and compliance the requirements. Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded. Preparation of Standard operating procedures related to Production activities. Monitoring of Dispatch activities. Preparation of Investigation report for production failure/deviations/OOS. Maintain accurate records of production data and prepare reports for plant Head. Identify and troubleshoot production issues to minimize downtime and maintain productivity. Develop and implement standard operating procedures to ensure consistent and efficient production processes. Participate in cross-functional teams to support new product development and scale-up of production processes
Responsible for review of intermediates and final products in accordance with the relevant specifications and methods of analysis/pharmacopoeias/in-house and customer specifications. Responsible for review of maintaining records. Responsible for review and ensuring calibration of equipments and instruments in ARD lab are carried out as scheduled. Responsible for issuing analytical reports/certificate of analysis for product as applicable. Responsible for making sure that ARD personnel are trained in their working area. Responsible for conducting/providing training for lab analysis on handling of hazards chemicals. Ensuring instruments calibrated are kept satisfactory working condition and maintaining log of all operations. Responsible for review of method development activities, analytical method validation protocol and reports. Responsible for review and approval of ARD SOPs. Ensure the compliance of SOPs and cGMP during batch operating. Identify and troubleshoot analytical issues to minimize downtime and maintain productivity. Support to cross-functional teams.