Title:  Manager - Projects (Process Equipment Filling)

Position:

Process Equipment- Filling

Job Title:

Process Equipment- Filling

Job Grade:

(G10 - Manager 1)

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 aseptic and lyophilisation 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.

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

BE Mechanical / Electrical

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

(5 to 10 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).