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Baxter India Pvt Ltd
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Sr Assoc - QA QMS

Sr Assoc - QA QMS

Baxter India Pvt Ltd

0 years

3 - 7 Lacs

Ahmedabad Gujarat India

Posted:23 hours ago| Platform: Foundit logo

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Skills Required

Corrective and Preventive Action (CAPA) Quality Control Qms

Work Mode

On-site

Job Type

Full Time

Job Description

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.

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