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 equipment 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 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 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.
- 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
B. Pharma / M. Pharma
