Senior Executive

Job Title:

Senior Executive

Business Unit:

Global Quality and Compliance

Job Grade

G11B

Location :

Dewas

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

1. Analytical data review: Responsible for review of analytical data and other data generated in QC laboratory (RM, PM Working Standard, Intermediate, Finish APIs, stability/hold time study, calibration, method validation/transfer, analyst qualification etc) as per SOP/Specification.
2. To prepare trend reports of review observations as per schedule.
3. LIMS: Ensure review and approval of specification/STP in LIMS.
4. Audit Trail Review: Ensure periodic Audit Trail Review of all computerized system (non-chromatographic) associated with QC Laboratory instruments.
5. EWS: Ensure review and approval of audit trail exceptions of Empower in EWS. Periodic audit trail review of EWS.
6. iLAB: To perform user access verification as per schedule.
7. Analytical method validation/Transfer: Ensure review/approval of protocol/reports and overall compliance as per SOP.
8. Trackwise: Ensure pre and post review/approval of lab event. Ensure evaluation and department review of CCR for SOP, specification, STP revision, instrument qualification etc, Involve as CFT for investigation of OOS/OOT, unplanned deviation, etc. in QC Laboratory. Initiation of CCR if required.
9. EDMS: Ensure review and approval of RA, SOP’s & Forms.
10. Regulatory filing: Ensure review of analytical data as per regulatory filing requirements.
11.  Ensure secured storage of old backup electronic data media (CV/DVD).
12. Ensure compliance relayed to QC.
13. Ensure issuance of logbook/Bound Book for QC Lab.
14. To support quality department for development and execution of new project at site.
15. Perform other duties assigned by Functional Head.

Travel Estimate

Job Requirements

Educational Qualification

B.sc/M.Sc / B.Pharm

Experience

Tenure:  8-10 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).