Job
Description
Job Description To follow the safety rules in the premises according to the company norms. To ensure aseptic area cleaning and fogging to coordinating with engineering department as per the schedule. To maintain online the BMRs and other log books in the respective area as per cGMP and SOP. Responsible for manufacturing and supervising of Media fill and Drug products batches as per BMR. Responsible to perform the in process checks during operation. Responsible for Dispensing, checking and receiving of the Raw Material from warehouse. Responsible for Area cleaning and Maintain the area properly for autoclave area. Responsible for operation and cleaning of area equipment present in the autoclave area like Pass boxes, Glove cleaning and integrity testers. Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the production area. Operation and cleaning of table mounted LAF and Ceiling mounted LAF and steam sterilizer and HPHV steam sterilizer Preparation of loads meant for Autoclaving like garments, disinfectant, filling, filtration, rubber stopper and seals for sterilization as per the validated load pattern. Responsible for Maintenance and cleaning of Component preparation and sterilization area (Autoclave area). To maintain the BMRs and other log books in the Component preparation and sterilization area (Autoclave area) as per cGMP and SOP. Monitoring of DP, RH and temperature in compounding and filtration area, autoclave area. Responsible for operation, calibration and cleaning of weighing balance, pH meter, DO meter and conductivity meter, Compounding isolator, Manufacturing and filtration vessels, Heating & cooling skid, Air shower. Table mounted LAF and ceiling mounted LAF, Filter integrity tester, Sonicator , TFF, Homogenizer, Lipid extruder, Fogger, Heating magnetic stirrer with thermometer, SART system, Strip chart recorder, HAWO pouch sealer. Responsible for the co-ordination with cross functional departments like QA, QC, warehouse Engineering, HR and administration for the day to day activities. Timely completion of SOPs training and on the job trainings related to autoclave area and filling area. Responsible for operation and cleaning of dynamic pass box in autoclave area and filling area. To carry out CIP & SIP of the vessels related to autoclave area and filling area. Responsible for timely completion of calibrations and validations activity in coordination with Engineering and QA related to autoclave area and filling area. Preparation and periodic revision of SOPs related to aseptic processing area. Responsible to perform the in process checks during filling. Qualifications Qualification - B Pharma, M Pharma About Us Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. About The Team The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs. Key Roles That The Human Resources Team Performs Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions. Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures. Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance. Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market. Show more Show less
