Title:  Sr. Manager - QE

Position:

QE Head

Job Title:

QE Head

Job Grade:

( G9B - Senior Manager 2)

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)

2 - 3

Job Summary

QE (Quality Engineer) Lead's responsibilities encompass leading a QE team, defining quality standards, developing testing strategies, and ensuring software quality throughout the development lifecycle. 

Areas of Responsibility

1) To aware about the process like vial washing, depyrogenation, filtration, filling, manufacturing, lyophilizer, component washing and sterilization,  terminal sterilization, isolators, CIP SIP skid, leak test, X ray inspection, VHP, clean utility like Clean steam, compressed air, PW and WFI generation system, AHU, FFM,

2) To handle the designing and qualification activity of Utility like Pure steam generation and distribution system, Purified water and WFI generation and distribution system, Nitrogen and compressed air generation and distribution system, AHU, FFM, LAF, area, cold storage etc

3) To handle preparation, review and execution of qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, operational qualification, performance qualification and Computer system validation and qualification

4) To prepare and execution of schedule requalification protocol of equipment’s and utility. 

5) To prepare new standard operating procedure for qualification activity and also review SOP of process equipment’s.

6) To handle communication with vendor and procurement team on design parts of new equipment’s.

7) Issuance, retrieval and storage of qualification documents.

8) Exposure of regulatory auditors like USFDA, EU, ANVISA, CANADA etc.

9) To handle the designing and qualification activity of process equipment’s like vial washing, tunnel sterilizer, filling machine, capping machine, Lyophilizer loading and unloading system, Lyophilizer, filtration skid, and isolators, VHP passbox, manufacturing skid, suspension manufacturing skid, CIP SIP skid for manufacturing and filtration equipment’s, dispensing isolators, manufacturing isolators, pH meter, DO meter, integrity tester, Autoclave, Terminal sterilizer, ultrasonication machine, GMP washer, external washing machine, leak test and X ray inspection machine, packing equipment’s etc.

10) To handle indenting to procurement of accessories and equipment’s required for qualification activity of above equipment’s and area.

11) To prepare schedule for qualification activity, calibration activity, updation of status label of qualification activity etc.

12) To handle the QMS documents like change control, CAPA, risk assessment, deviation etc.

13) To handle the QMS documents like change control, CAPA, risk assessment, deviation etc.

14) To ensure compliance to cGMP and documentation for various qualification activities.

15) 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.)

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

Experience

(12 to 15 Years of experience in relevant field in Pharmaceutical Industry.)

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).