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
