Sr Assoc - QA QMS, Baxter

Sr Assoc - QA QMS

Baxter

Location:

India, Ahmedabad

Category:

Quality Control

Contract Type:

Employment contract

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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