Production Operator - Sterile Filling

Role & responsibilities

1. To follow safety rules in the premises according to the company norms.
2. Responsible for operation and maintenance of Ampoule Filling machine & other equipment's of filling area of Pharma Sterile Injectable Plant.
3. Monitoring of DP, RH and temperature in aseptic processing area.
4. To maintain the BMRs and other log books in the aseptic processing area as per cGMP and SOP.
5. Responsible for operation and cleaning of area equipment present in the filling area
6. Responsible to perform the in process checks during filling.
7. To perform aseptic area cleaning and coordinating with engineering department as per the schedule.
8. Operation and cleaning of all Aseptic area equipment, change parts and storage as per the procedure.
9. Responsible for environmental monitoring of (Viable) aseptic processing area.
10. Responsible for the co-ordination with cross functional departments like QA, QC, warehouse Engineering, HR and administration for day to day activities.
11. Responsible for timely completion of calibrations and validations in coordination with engineering and QA related to aseptic processing area.
12. Responsible for cleaning verification and preparation of filling parts for autoclaving.
13. Timely completion of SOPs training and on the job trainings related to aseptic processing area.
14. 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.
15. 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