Manager - Projects (Process Equipment)

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 manufacturing and component washing and sterilization area.
• To handle process like manufacturing of liquid product including media, complex injectable and suspension manufacturing.
• To handle the process equipment’s in manufacturing like manufacturing skid, filtration skid, suspension manufacturing skid, CIP SIP skid for manufacturing and filtration equipment’s, dispensing isolators, manufacturing isolators, pH meter, DO meter, integrity tester etc.
• To handle component washing and sterilization area and its equipment’s like Autoclave, Terminal sterilizer, ultrasonication machine, GMP washer, VHP pass box, external washing machine, leak test and X ray inspection machine etc.
• To handle indenting to procurement of new manufacturing equipment’s as well as component washing and sterilization equipment’s as mentioned above.
• To ensure compliance to cGMP and documentation for various production activities
• Experience for preparation and execution of qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, operational qualification and performance qualification.
• To prepare of 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
• 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

Specific Certification

Skills

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

Experience

Age 27 to 32 years.

Disclaimer: