Associate, Filling

To follow safety rules in the premises according to the company norms.

• 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 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 to perform the in process checks during filling
• To perform aseptic area cleaning and fogging to coordinating with engineering department as per the

schedule

• Operation and cleaning of all Aseptic area equipment, change parts and storage as per the procedure
• Operation and Cleaning of heating cooling skid, CIP & SIP skid
• 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 equipments 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