Baxter Microbiology Quality Associate Job Opening – Apply Online
Position: Assoc, Quality – Micro
Req #: JR – 118522
Location: Ahmedabad, Gujarat, India
Job Category: Quality
Date posted: 11/13/2023
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.
Job Responsibilities
- Prepare Standard Operating Procedure (SOP)/documents/Investigation for Microbiology lab and report to Supervisor and Quality Assurance (QA), if the non-conformity is observed.
- 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.
- Access the impact of functional and cross-functional document change control (DCR) or change control management (CCM).
- Complete the impact of functional and cross-functional non-conformity and OOS in co-ordination with area manager.
- Perform investigation non-conformity identified.
- Initiate CCM and impact assessment of the cross functions through QMS.
- Prepare error-free documents as per Corrective and Preventive Action.
- Impart training to concerned personnel as per requirement.
- Handle QMS documents and relative documentation to its closure in defined timeline.
- Prepare SOP and update according to cGMP requirements or any observation.
- Perform tasks assigned by management from time to time.
- Prepare and analyze non-conformity or Out of Specification line wise.
- Ensure cGMP violation escalation to the Supervisor for their attention and to seek the solution.
- Escalate any non-compliance observed on the shop floor to Supervisor.
- 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 regulatory guidelines.
- Coordinate with QA/QC/QMS/Audit & Compliance personnel for implementation of the current/revised standard testing procedures, specifications, and methods of analysis.
- Draft audit/inspection responses to regulatory agencies and have knowledge of different regulatory guidelines.
- Handle external and internal audits and ensure effective implementation of CAPA.
- Prepare risk analysis documents for different microbiological processes.
- Prepare inspection plans for various components and have proficiency in managing Regulatory & Customer Audits.
- Conduct periodic compliance checks to ensure good health of Microbiology function.
Application Instructions
Apply online for the Baxter Microbiology Quality Associate position by clicking here.
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