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Ahmedabad

    Sr Assoc, Quality - Ahmedabad, India - Baxter

    Baxter
    Baxter Ahmedabad, India

    2 weeks ago

    Default job background
    Full time
    Description

    This is where you save and sustain lives

    At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

    Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

    Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

    Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

  • To prepare Standard Operating Procedure (SOP)/documents/Investigation for Microbiology lab and report to Supervisor and Quality Assurance (QA), if the non-conformity is observed.
  • To initiate the change in process, equipment or facility as per operational requirement.
  • Timely closure of CAPA/NCR/LIR and quality documents related to Microbiology lab.
  • To access the impact of functional and cross functional document change control (DCR) or change control management (CCM).
  • To complete the impact of functional and cross functional non-conformity and OOS in coordination with area manager.
  • To perform investigation non-conformity identified.
  • To initiate CCM and impact assessment of the cross functions through QMS.
  • To prepare error free document as per Corrective and Preventive Action.
  • To impart the training to concerned personnel as per requirement.
  • To handle QMS documents and relative documentation to its closure in defined timeline.
  • To prepare SOP and update according to cGMP requirements or any observation.
  • To perform the task, which is assigned by the management from time to time.
  • To prepare and analyze the non-conformity or Out of Specification line wise.
  • To ensure cGMP violation escalation to the Supervisor for their attention and to seek the solution. To escalate any non-compliance observed on shop floor to Supervisor.
  • To intimate and discuss the non-conformity report and its impact with Supervisor and implement appropriate CAPA.
  • Escalate any delay in execution of change controls and CAPA generated through QMS elements Prepare SOP, protocols, standard testing, specification as per the regulatory guidelines.
  • Coordinate with QA/QC/QMS/Audit & Compliance personnel for implementation of the current / revised standard testing procedures, specifications and method of analysis.
  • To draft audit/inspection response to regulatory agency and having the knowledge of different regulatory guidelines.
  • To handle external & internal audits and ensure effective implementation of CAPA.
  • To prepare risk analysis documents for different microbiological processes.
  • To prepare inspection plans for various components proficiency in managing Regulatory & Customer Audits.
  • To conduct periodic compliance checks to ensure good health of Microbiology function.
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