Manager - Projects (Process Equipment Installation)

Position

Job Title

Job Grade

(G10 - Manager 1)

Function

Sub-function

Manager’s Job Title:

Skip Level Manager’s Title

Function Head Title:

Location:

No. of Direct Reports (if any)

Job Summary

Areas of Responsibility

• To handle aseptic and lyophilisation 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.
  

Travel Estimate

Medium

Job Scope

Internal Interactions (within the organization)

External Interactions (outside the organization)

Geographical Scope

Financial Accountability (cost/revenue with exclusive authority)

Job Requirements

Educational Qualification

BE Mechanical / Electrical

Specific Certification

Skills

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

Experience

Age 27 to 32 years.

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