BABaxter India Pvt Ltd
Sr Assoc - QA QMS
Ahmedabad ₹3-8 LPA Posted 10 Apr 2025
FULL TIME
Qms
Quality Control
Quality Assurance
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.