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Sr Assoc - QA QMS

https://www.baxter.com/ Logo

Baxter

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Location:
India, Ahmedabad

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Category:
Quality Control

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

This role ensures the implementation and maintenance of Quality Management Systems (QMS) while supporting compliance with global quality metrics. The candidate will assist in process improvements, audits, and managing non-conformities while contributing to the continuous improvement of quality functions.

Job Responsibility:

  • Ensure the implementation and maintenance of Quality Management System elements at the site
  • track and implement improvement objectives identified during quality metrics presentations
  • review and approve Out of Specifications (OOS) results, ensuring timely assessment for Field Alert Report (FAR) or regulatory actions
  • conduct site management reviews, NCR, OOS/OOT/OOL, and Change Control review meetings on time
  • support external and internal audits at the site, providing observations related to QMS compliance
  • monitor and ensure key performance indicators are maintained periodically and achieved.

Requirements:

  • Ensure the implementation and maintenance of Quality Management System elements at the site
  • achieve compliance with global quality metrics and submit quality metrics data to the QA Head and management on time
  • track and implement improvement objectives identified during quality metrics presentations
  • evaluate departmental efficiency and ensure required training for cross-functional team members is provided
  • assist the QA Head in implementing Electronic Quality Management System (E-QMS) modules to handle QMS elements effectively across the plants
  • ensure non-conformities (NCR/SNCRs) are adequately investigated, root causes identified, and effective Corrective and Preventive Actions (CAPA) are implemented
  • review and approve Out of Specifications (OOS) results, ensuring timely assessment for Field Alert Report (FAR) or regulatory actions
  • ensure Out of Trend (OOT), Out of Limit (OOL), and Laboratory Investigation Reports (LIR) are adequately investigated
  • review and approve Change Control Management (CCM) and Document Change Requests (DCR) as per Standard Operating Procedures
  • monitor and ensure key performance indicators are maintained periodically and achieved
  • ensure data reliability is in place
  • conduct site management reviews, NCR, OOS/OOT/OOL, and Change Control review meetings on time
  • attend CAPA review board meetings and monthly quality metrics review meetings on time
  • support external and internal audits at the site, providing observations related to QMS compliance
  • communicate cross-functional requirements to concerned personnel and functions
  • maintain and monitor the functional budget periodically
  • support quality functions as required by the business
  • inform key management teammates about critical quality-impacting QMS elements and raise concerns about potential deviations that could affect quality metrics.
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Health & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer.

Additional Information:

Job Posted:
March 20, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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