Senior Manager - Process Equipment Filling

Position

Job Grade

(G10 - Manager 1)

Function

Location:

Job Summary

Area s of Responsibility

• To handle aseptic and lyophilization area.
• To handle process like filtration, filling, Lyophilizer loading and unloading, lyophilisation process, capping, leak test and X ray inspection.
• 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.
• To handle indenting to procurement of new equipment’s of aseptic area and lyophilizer area as mentioned above.
• To handle preparation and execution of qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, operational qualification and performance qualification.
• To prepare new standard operating procedure for process and equipment’s.
• Experience for preparation of batch manufacturing records.
• To handle the QMS documents like change control, CAPA, risk assessment, deviation etc
• To handle communication with vendor and procurement team on procurement to design parts of new equipment’s.
• To ensure compliance to cGMP and documentation for various production activities.
• Ensure proper planning and execution of the qualification activity in accordance with the plan and allocation of man power.
  

Job Requirements

Educational Qualification

BE Mechanical / Electrical

Skills

Technical Skills/Competencies (Software packages, experience with specific machines etc.)

Experience