Roles and Responsibilities:
Vial Washing Operator :
1.Changeover, cleaning & operation of Vial washing, Tunnel, Sealing machine and external washing machine.
2.Depacking & pre- inspection of vials.
3.Monitoring of in process checks during activities as per BPCR/ SOP.
4.Cleaning of vial washing machine RW, PW & WFI filters and integrity testing of compressed air filter.
5.Sanitization of tunnel.
6.Verification of validated parameters before proceeding to activity.
7.Ensuring Cleanliness of Non APA.
8.Compliance to gowning and de-gowning procedure for entry & exit into clean rooms.
Aseptic Operator :
1.Operation of filling machines, sealing machines, cRABs, VHP Generators, and GLT machines.
2.Unloading of sterilized items, assembling, VHP sterilization, filling, stoppering (partial/ full),
filled vials loading into lyophilizer, unloading of lyophilized vials and sealing of full stoppered
vials.
3.Cleaning, inspection, integrity testing & replacement of APA RABs gloves as per frequency
mentioned in respective SOPs.
4.Participation in Disinfectant filtration, APA area cleaning and documentation.
5.Participation in filtration activities and integrity testing of filters.
6.Ensuring availability of sufficient garments, shoes and Disinfectant solution.
7.Follow up and compliance to preventive maintenance of equipment and calibration of
temperature gauges, pressure gauges, RTDs etc.
Desired Candidate Profile:
- Educational Qualification : Diploma, B.Sc
- Experience : 1 to 5 Years
- Formulation Experience Preferable