Associate Filling

Job Description

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

Qualifications

qualification - B.Pharmacy

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