Sr Executive I, Quality Assurance

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

1. To take instructions from supervisor or QA Head to manage Document Control activity.

2. To ensure the implementation and maintenance of current Good Manufacturing Practice (cGMP) standards.

3. To review and verify that any GDP issues have been addressed.

4. To issue and close Logbooks to the respective plant, as per request of respective department from Controlled Forms System (CFS).

5. To archive executed Logbooks, Standard Formats, Batch Manufacturing Record in the record room and submit to central record room.

6. To issue completed records from record room and ensure its storage, achieve & timely disposition.

7. To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for each new product introduced for manufacturing, whether for regulatory filings (exhibit batches) or for commercial distribution (approved products).

8. To review BMR based on initial product transfer input received from Quality or F&D / TTD as per requirement.

9. To Prepare / review BMRs and BPRs by integrating product specifications from Technical Package (TP) and processing parameters from site.

10. To verify BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) in TcU, based on approved BMRs and BPRs production planning schedule and after generating a batch number assignment.

11. To review departmental Standard Operating Procedure and keep it updated by providing inputs for IPQA functions as per regulatory guidelines.

12. To maintain Bill of material, Creation of HALB code in JDE.

13. To review cross-functions Standard Operating Procedure and keep it updated by providing inputs for Document Control functions as per regulatory guidelines.

14. To prepare annual product review report and submit to IRA for dossier updation

15. To prepare change control management (CCM) or document change request (DCR) for Document Control.

16. To raise Non-conformance Report (NCR) and complete investigation report with appropriate correction and/or preventive actions if any non-compliance occurred during execution of Document Control activity.

17. To perform execution task for Corrective Action and Preventive Action.

18. To perform execution task for Change Control Management.

19. To prepared, review or revised SOPs at regular interval to meet regulatory requirement or complies internal audit observation (if any).

20. To support cross-functional department staff for any Batch records related query resolution.

21. To generate and review stability intimation slip in ELN.

22. To seek area of improvement from QA Head and implement action plan.

23. To communicate any failure or abnormal notification to Supervisor and QA Head for their attention and seeking for the solution.

24. To communicate any gap or abnormality observed during data verification to Supervisor or QA Head.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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