Sr Spec, Quality Compliance

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.

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