BAXTER

Quality Engineer, Validation

Ahmedabad, Gujarat Full time

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 assess the process proactively and perform a pFMEA.

2.      To co-ordinate with cross functional SMEs for brainstorming and accomplishing the pFMEAs.

3.      To conduct a thorough review with the Cross functional SMEs of the processes to identify potential failure modes, assessing risks, developing action plans, and ensuring implementation and continuous improvement of the process to enhance quality and reliability. 

4.      Timely escalate and communicate the risk to the stakeholders and support for devising the mitigation actions.

5.      To track and monitor the pFMEAs on continual basis assuring their effectiveness, adequacy & accuracy of the documents.

6.      To evaluate the impact on the existing or requirement of any new pFMEA as part of the new CCMs or change in the existing process/manufacturing lines

7.      To initiate the revision of the impacted pFMEA documents in accordance with the impact assessment conducted for the corresponding CCM.

8.      To keep stakeholders & seniors informed about the progress of the pFMEA, the implementation of action plans, revision/CAPAs if any.

9.      To provide the management with the necessary insights regarding the quality and reliability of processes or methodologies which ensures the compliance with process standards, product quality, and patient safety but also contributes to time and cost savings.

10. To oversee the entire NPI project, managing timelines.

11. To act as the central point for Quality related activities for the New Product introduction (NPI) at the site/plant, ensuring alignment across different departments. 

12. To gather input from product development, manufacturing, marketing, and other relevant teams to define action/execution plan. 

13. To facilitate communication and collaboration between various teams throughout the NPI process. 

14. Coordinate cross-functional meetings and ensure all team members are aligned on project goals and deliverables.

15. Identify and manage potential risks and issues that may arise during the NPI process.

16. Ensure site readiness per all quality requirement for product launches, including facilities, equipment, and personnel.

17. To identify and coordinate with the quality stakeholders for GMP projects.

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.

Recruitment Fraud Notice

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