Title:  QA Head

Job Title:

Senior Manager - QA Head

Business Unit:

Quality

Job Classification Code:

New

Function:

Global Quality & Compliance

Grade :

G9A

Location

Central India (Greenfield Project)

Key Responsibilities

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Position Summary –

QA Head (Quality Assurance Head) is a leadership role responsible for ensuring the quality and safety of all products and processes, adhering to Good Manufacturing Practices (GMP) and regulatory standards, and overseeing the QA team

Responsibilities-

Expertise in qualification of below process and equipment’s:

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 steam, compressed air, PW and WFI generation system, AHU, FFM,

2) To handle the designing and reviewing of 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.

3) To handle the designing and reviewing of 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. 

4) To review qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, Operational qualification, performance

    -  qualification and Computer system validation and qualification.

    - To ensure compliance to cGMP and documentation for various production activities.

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

6) To review schedule for qualification activity, calibration activity, updation of status label of qualification activity etc.

7) To review the QMS documents like change control, CAPA, risk assessment, deviation etc.

8) To involve during communication with vendor and procurement team on procurement to design parts of new equipment’s along with operation and CFT.

9) Ensure proper planning, execution of the qualification activity in accordance with the plan and allocation of man power

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

Travel Estimate

Low

Job Scope

Job Requirements

Educational Qualification

B.Pharm / M.Pharm

Experience

Tenure: 16 to 17 Years (Pharmaceutical Industry experience with Injectable formulation site)

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

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).