Job Description :
Follow SOPs, BMR instructions, CGMP, safety norms. Smooth running of entire vial line along with Lyophilzer loading and unloading independently. Validation and qualification (ReValidation and Requalification) of entire vial line along with Lyophilzer loading and unloading. Operation / calibration / PPM activities of entire vial line along with Lyophilzer loading and unloading. Documentation of activity related to entire vial line along with Lyophilzer loading and unloading.
B) Section: Vial washing and component sterilization area
Job Description :-
Follow SOPs, BMR instructions, CGMP, safety norms. Smooth running of vial washing, tunnel along with Autolcaves and VHP. Validation and qualification (ReValidation and Requalification) of vial washing, tunnel along with Autolcaves and VHP. Operation / calibration / PPM of vial washing, tunnel along with autoclaves and VHP Documentation of activity related to vial washing, tunnel along with Autoclaves and VHP. Should also possesses area qualification and re-nullification activities. Deviation, change control and CAPA monitoring and Closure of the department. BMR, SOP, FMECA ( risk analysis) preparation and revision of the department.
0 Comments