Title:  Senior Manager - Process Equipment Filling

Areas of Responsibility

1)      To handle aseptic and lyophilization area.

2)      To handle process like filtration, filling, Lyophilizer loading and unloading, lyophilisation process, capping, leak test and X ray inspection.

3)      To handle the process equipment’s like vial washing, tunnel sterilizer, filling machine, capping machine, Lyophilizer loading and unloading system, Lyophilizer, filtration skid, and isolators, VHP passbox etc.

4)      To handle indenting to procurement of new equipment’s of aseptic area and lyophilizer area as mentioned above.

5)      To handle preparation and execution of qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, operational qualification and performance qualification.

6)      To prepare new standard operating procedure for process and equipment’s.

7)      Experience for preparation of batch manufacturing records.

8)      To handle the QMS documents like change control, CAPA, risk assessment, deviation etc

9)     To handle communication with vendor and procurement team on procurement to design parts of new equipment’s.

10)   To ensure compliance to cGMP and documentation for various production activities.

11) Ensure proper planning and execution of the qualification activity in accordance      with the plan and allocation of man power.