Production Operator - Sterile Filling

Role & responsibilities

• To follow safety rules in the premises according to the company norms.
• Responsible for operation and maintenance of Ampoule Filling machine & other equipment's of filling area of Pharma Sterile Injectable Plant.
• Monitoring of DP, RH and temperature in aseptic processing area.
• To maintain the BMRs and other log books in the aseptic processing area as per cGMP and SOP.
• Responsible for operation and cleaning of area equipment present in the filling area
• Responsible to perform the in process checks during filling.
• To perform aseptic area cleaning and coordinating with engineering department as per the schedule.
• Operation and cleaning of all Aseptic area equipment, change parts and storage as per the procedure.
• Responsible for environmental monitoring of (Viable) aseptic processing area.
• 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.
• Responsible for cleaning verification and preparation of filling parts for autoclaving.
• Timely completion of SOPs training and on the job trainings related to aseptic processing area.
• Operation and cleaning of all equipment's like CIP / SIP for vessels before starting of the batch process and after completion of the batch process related to filling and filtration.
• Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance

Preferred candidate profile   : - Previous working experience as Filling operator is must

Skills Required

Sterile, Production Operations, Sop, cip, Sip