Assoc, Production

3 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.

1. To prepare and review manufacturing investigations related to NCR /OOS/OOT/OOL/market complaints to identify the root cause and implementation of appropriate CAPA.

2. To prepare and review risk assessment for associated QMS element & ensure completion of risk assessment in timely manner.

3. To define the CAPA and its effectiveness check.

4. To initiate Change Control for any changes, execution and Change Control closure in timely manner.

5. To handle Document change request/ Change control and impact assessment of the cross functional department.

6. Handling of QMS activities in Track wise software.

7. To prepare and review Standard Operating Procedure (SOP), Exhibit, Standard Format in TcU and ensure the documents are in line with current Good Manufacturing Practice (cGMP) requirements

8. To escalate any delay in investigation or QMS elements to supervisor & ensure closure of the same within defined timeline.

9. To complete training on assigned SOPs in BAXU system in timely manner & ensure completion of such training completion by team.

10. To track all open QMS elements & ensure closure of such elements with effective CAPA within defined timeline.

11. To coordinate with Training and Development department for initiation, effectiveness, and closure of training.

12. To perform the GEMBA as part of investigation, if required.

13. To attend and implement training related to Quality Management System (QMS) and current Good Manufacturing Practice (cGMP) .

14. To check data integrity & compliance of all processes & systems is being maintained at all levels by frequent GEMBA.

15. To face internal or external current Good Manufacturing Practice (cGMP) regulatory audits & respond to the auditors’ queries. Also ensure audit preparedness in the function.

16. To inform supervisor/individual regarding a safety/ Hazard concern in area.

17. To perform task assigned by management time to time.

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