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Description
Job Description To follow safety rules in the premises according to the company norms. To maintain the BMRs and other log books in the aseptic processing area as per cGMP and SOP. Preparation and periodic revision of SOPs related to aseptic processing area. Monitoring of DP, RH and temperature in aseptic processing area. Responsible to perform the in process checks during filling. To ensure aseptic area cleaning and fogging to coordinating with engineering department as per the schedule. Operation and Cleaning of heating cooling skid, CIP & SIP skid. Responsible for environmental monitoring of (Viable) aseptic processing area. Timely completion of SOPs training and on the job trainings related to aseptic processing area. To ensure all equipments cleaning activity like CIP / SIP for vessels before starting of the batch process and after completion of the batch process related to filling and filtration. To ensure all aseptic processing area equipment's change parts cleaning and storage as per the procedure. Responsible for cleaning verification and preparation of filling parts for autoclaving Responsible for operation and cleaning of area equipment present in the filling area like filling machine, Rubber stoppering, sealing machines, Isolators, Pass boxes, Glove cleaning and integrity testers including VHP. Responsible to carry out the filling, stoppering, lyophilization and sealing operations as per the SOP and BMR. Responsible for the co-ordination with cross functional departments like QA, QC, warehouse Engineering, HR and administration for day to day activities. Responsible for timely completion of calibrations and validations in coordination with engineering and QA related to aseptic processing area. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance. Qualifications Qualification - B. Pharma, M.Pharma, B Tech, Diploma 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
