Title:  40023037 - QA - QMS - G11A - Halol - II

Job Title:

Manager-1

Business Unit:

Sun Global Operations

Job Grade

G10

Location :

Halol

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.”

Key responsibilities:

Job Summary

To work as an investigator and all the assigned tasks given to him is completed within the predefined timelines. No delays in execution of the defined activities and updation of results. Any cross-functional support shall be discussed and cleared in shortest possible time. Shall be responsible for the monitoring of health of Quality Management system (QMS). Should ensure the closure of all QMS elements within the defined timelines assigned. No extensions or delays shall occur for the defined activities. Ensure the compliance and readiness of microbiology laboratory for the inspection with the objective of ensuring that the quality of product tested and manufactured and released are with adherence to GMP norms and timelines.

Areas Of Responsibility

1. Ensure the compliance in the microbiology laboratory.
2. To monitor the health of Quality Management System (QMS).
3. To perform the investigations pertaining to deviations (EM and laboratory), laboratory events, Out of specification (OOS), Out of Trends (OOT).
4. To provide support to cross-functional team in any investigation and identification of Root Cause Analysis (RCA) and CAPA.
5. To review and update the SOPs pertaining to investigations are in-line with the recent developments or observations from the regulatory perspective.
6. To be part of the audit team and ensure audits are completed within the define timelines.
7. To be an auditee in internal and corporate audits.
8. To prepare audit response for all observations within the defined timelines.
9. To track and ensure that all the proposed corrective and preventive actions (CAPA) are closed within the defined timelines.
10. To track and ensure that all the change controls are closed with the defined timelines.

Travel Estimate

Job Requirements

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

12+ Years

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).