Title:  Senior Officer - Quality Assurance

Job Title:

Senior Officer

Business Unit:

Global Quality and Compliance

Job Grade

G12B

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. Batch Release: To perform usage decision of finished product, Intermediate and recovered solvent batches and ensure all requirements as per SOPs, Specifications, Customer & Regulatory Commitments, Exhibit / PPQ Batch Protocol (as applicable) are complied prior to taking Usage Decision on a batch.
2. To perform sampling and sample distribution of Finished Product & Intermediates as per SOP.
3. Control and review of Batch production records of APIs, intermediate & recovered solvents of all API plants.
4. To review of batch production records and analytical records before release of batches for distribution and to release delivery order.
5. Preparation and review of Annual Product Review as per SOP.
6. Management of Retention samples including annual inspection of API and to maintain related records.
7. To perform following activities in Track wise (CQMS) system as per requirement.

-Sampling investigation

-QA review and verification tasks

-Initiation of change controls and investigation/deviation.

8. To perform environmental monitoring of general API plants, preparation and review of trend and its evaluation as per SOP.
9. To provide market and regulatory samples as per requirement.
10. Generation, logging, monitoring and closure of TRF as per SOP.
11. Trending of analytical data for APIs as per SOP.
12. To provide accurate and adequate data to Marketing Regulatory Affairs department for filing to various regulatory agencies.
13. Preparation and maintenance of finished product label in system for APIs and perform reconciliation of API FG labels.
14. Work allotment and planning.
15. To perform transport validation activity as per SOP.

1. Handling of market returned materials as per SOP.

Travel Estimate

Job Requirements

Educational Qualification

B.sc/M.Sc / B.Pharm

Experience

Tenure:  2-5 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).