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Senior Associate - QA QMS

4.00 to 8.00 Years   Ahmedabad   04 May, 2023
Baxter India
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaFinance / Accounts / Tax
EmploymentTypeFull-time

Job Description

    Sr Assoc - QA QMS
    • To ensure implementation and maintenance of Quality Management System elements at site.
    • To ensure the quality metrics compliance as per Global Quality metrics.
    • To ensure the submission of quality metrics data to QA Head and management on time.
    • To ensure the improvement objectives identified during quality metrics presentations are effectively tracked and implemented.
    • To evaluate the efficiency of the department and ensure that required training imparted to cross functional team members.
    • To assist QA Head in implementation of Electronic Quality Management System (E-QMS) modules to handle Quality Management System elements effectively across the plants.
    • To ensure that the non-conformities (NCR/SNCRs) are adequately investigated, root causes are identified and effective Corrective and Preventive Actions (CAPA) are taken and implemented.
    • To review/approve and ensure that Out of Specifications (OOS) results are investigated and assessed for Field Alert Report (FAR) or regulatory actions within timeline.
    • To ensure that the Out of Trend (OOT), Out of limit (OOL), Laboratory Investigation Report (LIR) are adequately investigated.
    • To review/approve and ensure that the Change Control Management (CCM) & Document Change Request (DCR) are assessed and closed as per Standard Operating Procedure.
    • To monitor & ensure key performance indicators are maintained periodically and ensure these are achieved.
    • To ensure data reliability is in place.
    • To conduct the site management review & NCR, OOS/OOT/OOL, Change Control review meeting on time.
    • To attend the CAPA review board meeting on time.
    • To attend monthly quality metrics review meeting on time.
    • To support in external & internal audit at site.
    • To provide the audit observation related to compliance of QMS elements.
    • To ensure that the cross functional requirements are communicated to concerned personnel & functions.
    • To maintain functional budget & monitor the same on periodic basis.
    • To support the quality functions as when and required by business.
    • To communicate if any abnormality or potential non-conformities observed during document review or plant visit to QA Head.
    • To provide the notification to key management teammates for critical quality impacting QMS elements.
    • To escalate the management for potential drift which could impact the quality metrics from the regular trend.
    ,

Keyskills :
quality management systemboard meeting

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