Sr Exec, QA

2 weeks ago

ahmedabad, India Baxter Full time

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

KEY RESPONSIBILITIES & AUTHORITIES Tasks: (list of tasks/ activities related to the Job Role)

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. 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.

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