Sr Spec, Quality Compliance

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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential

Sr Spec, Quality Compliance

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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 Responsible for Internal Audits, External Audit, Audit readiness, Regulatory Intelligence and Global Observation Certification. Ensure compliance with Baxter policies, procedures, and regulatory requirements.
2 To maintain the schedule of the Internal audits and perform internal quality audits to ensure the compliance to all quality systems and procedures.
3 To perform system and facilities review as per the regulatory requirements and expectations to support all time readiness of site for internal/external audits.
4 To verify process and systems are complying standard operating procedures (SOPs) and current regulatory requirements and expectations.
6 To assist Compliance Head or Site Quality head in hosting external inspections and facilitating site audit compliance responses by coordinating with cross functional departments.
7 To be responsible for arranging pre-requisite and audit agenda requirements and ongoing inspection requests if any.
8. To ensure that the audit commitments compliance and its effectiveness.
9. To handle QMS elements with Trackwise for audit commitments keep track of the same to closed within timeline.
10. Ensuring All time readiness of the site for any regulatory audit and inspection.
11.To establish clear policies, processes and metrics are in line with the Business strategy and Regulatory requirements which are instrumental in driving consistency and compliance.
12. To communicate and co-ordinate with cross functional teams and SLTs for activities related to Compliance, Quality Management System, Inspection Management.
13 To perform approval of Document Change Request (DCR), Change Control Management (CCM), Non-conformance, CAPA and other QMS elements as and when required and prepare/review documents with Team Center Unify (TCU) and other suitable tools as applicable.
14. To perform GEMBA walk and ensure mitigation of observation.
15. To ensure compliance verification of regulatory intelligence gap assessment, global observation certification, quality alert assessment, corporate hold assessment etc. as and when received.

To partner with Regulatory Affairs for providing site related information and documents for application of current Good Manufacturing Practices (cGMP).
16. To oversee Quality Key Performance Indicators (KPI) and improve the scores in liaison with Cross Functional Teams. Reporting on the performance of the QMS and any need for improvement to QMR and MWER.
17. To ensure the CGMP compliance status of site as per the regulatory requirements and expectations based on the current inspection/ industrial trends as part of continuous improvement; and promote awareness of regulatory and customer requirements throughout the organization.
18. To review, approve or reject Quality Management System elements and actions; and ensure timely closure of QMS elements and effectiveness of the implemented CAPAs at departmental level.
19 To ensure that Data integrity is being maintained at all levels and to ensure that system is in state of control.
20 To partner with the Leaders and Team Members to establish clear, consistent and efficient quality culture, processes and practices at site. Enabling scalability of the business while ensuring quality and compliance in product manufacturing life cycle.

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

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Explore this location Sarkhej - Bavia Road
Chacharvadi Vasna
Ahmedabad- 382213
Gujarat
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Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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Sr Spec, Quality Compliance

Overview

Success Profile

Sr Spec, Quality Compliance

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Hear from Our Employees

Meet Christelle, Senior Quality Manager in Malta

Meet Lorena, Senior QA Associate in London, UK

Meet Gary, Quality Research Manager in Singapore

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Join Our Talent Community