Senior Officer

Job Title:

Senior Officer

Business Unit:

Quality Control

Job Grade

G12B

Location :

Toansa

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. Planning and execution for analysis of working standards, calibration, method validation and method transfer and reviewing all related analytical data.

2. To ensure completion of the working standard testing and related documents before usage and to ensure the completeness of documents as per SOP on GDP.

3. To ensure completion and accuracy of all analytical reports generated completeness and reliability before release of analytical data.

4. To ensure all laboratory instruments are qualified, calibrated and maintained as per schedule and requirement of SOP.

5. Monitoring and control of storage and labeling of working/reference standards.

6. Coordinate for procurement of reference standards/impurity standards.

7. Maintenance and general cleanliness of refrigerator and other instruments used for storage of working standard.

8. Maintenance of assurance and disposal record of working standard.

9. Maintain instrument and related spare/consumables/chemicals inventory and record thereof.

10. Communication to section in charge for OOS/OOT results/deviations/instrument breakdowns.

11. Other documentation of the following:

   - Usage record of working/reference standards

   - Raw data and calculations

   - Monitoring of storage conditions

12. Preparation and review of Test Protocol of working standard for completeness and adequacy as per applicable specifications/STPs.

13. Retrieval and archival of quality control records provided by section in-charges in QC compactor room as per SOP.

14. To ensure compliance to regulatory requirement (21 CFR Part 11) in all laboratory instrument software in the section.

15. General compliance of Good Laboratory Practices.

16. Handling of qualification activities of lab instruments.

17. Participation in internal/external and/or regulatory inspections of QC operations at the site.

18. Usage of safety appliances during analysis where required. Maintain safe working environment in the laboratory.

19. Training in LMS as per TNI.

Travel Estimate

Job Requirements

Educational Qualification

B.Sc./ B Pharma/ M.Sc. (Chemistry)

Experience

Tenure:  06 years to 10 Years, Strong knowledge of cGMP, FDA regulations, and industry best practices

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).