Title:  Senior Manager - Projects (Process Equipment)

Position:

Senior Manager - Projects (Process Equipment)

Job Title:

Senior Manager - Projects (Process Equipment)

Job Grade:

(G9B- Sr. Manager)

Function:

PROJECTS

Sub-function:

Manager’s Job Title:

Skip Level Manager’s Title:

Function Head Title:

Location:

Central or South India (Greenfield Project)

No. of Direct Reports (if any)

Job Summary

He will lead Installation commissioning of Ophthalmic and Injectable facility Process equipment’s. He is responsible for timely completion of project as per defined quality and cost.

Areas of Responsibility

1. To handle manufacturing and component washing and sterilization area.
2. To handle process like manufacturing of liquid product including media, complex injectable and suspension manufacturing.
3. 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.
4. 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.    
5. To handle indenting to procurement of new manufacturing equipment’s as well as component washing and sterilization equipment’s as mentioned above.
6. To ensure compliance to cGMP and documentation for various production activities
7. Experience for preparation and execution of qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, operational qualification and performance qualification.
8. To prepare of new standard operating procedure for process and equipment’s.
9. Experience for preparation of batch manufacturing records.
10. To handle the QMS documents like change control, CAPA, risk assessment, deviation etc.
11. To handle communication with vendor and procurement team on procurement to design parts of new equipment’s
12. 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)

Check in Internal as well as External both

External Interactions (outside the organization)

Check in Internal as well as External both

Geographical Scope

Financial Accountability (cost/revenue with exclusive authority)

Job Requirements

Educational Qualification

B. Pharmacy, M. Pharmacy

Specific Certification

Skills

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

AutoCAD, MS Office, MS Projects, Primavera.

Excellent communication skills, strong collaborator, problem solving, interdepartmental coordination, team leadership.

Experience

(12 to 15 Years of experience in relevant field in Pharmaceutical Industry.) Age   27 to 32 years.

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).