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Assoc, Quality Assurance - IPQA

3.00 to 6.00 Years   Ahmedabad   30 Sep, 2021
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Assoc, Quality Assurance - IPQAApply Now Save JobThis is where you save and sustain livesAt 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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters 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 take instructions from Sub-department Manager to manage shift activity.
  • To do analysis of headspace oxygen and dissolve oxygen during in process monitoring.
  • To verify primary raw material, primary packing material at the time of material issuance and material dispensing against Technical Package or Standard Material Requirement Form and approve the process step.
  • To perform routine IPQA monitoring like volume check, critical control step verification during manufacturing of the product, sampling and periodic verification activities and if any non-conformity or abnormal observation in terms of noncompliance to Good Manufacturing Practice (GMP) observed, bring to the notice of Shift Manager and Sub-department Manager.
  • To verify sample, good destruction process and report any gap to Department Head and take corrective and preventive action in coordination with respective Department Head.
  • To carry out reconciliation and physical verification of the returned goods.
  • To ensure that finished product samples are collected from defined location and submit it to QC after visual inspection.
  • To ensure logbooks, online documents, records, analysis report and other supporting documents related to products manufactured in the plant.
  • To ensure provide support to Sub-department Manager in investigation, in case of any product complaints or non-conformities or Out of Specification.
  • To execute the Corrective and Preventive Action (CAPA) defined by Quality Management System (QMS), as per instruction of Sub-department Manager.
  • To raise Document Change Request (DCR) and Change Control Management (CCM) and track the same and ensure closure as per Standard Operating Procedure.
  • To help Sub-department Manager in preparation, review, implement and update SOP s according to current regulations systems.
  • To give non-compliance reports to the respective departments in case of internal quality audits and report it to Sub-department Manager and Department Head.
  • To provide line-clearance for routine manufacturing activity and dispensing activity, monitor each line & sample collection at regular interval.
Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .,

Keyskills :
correctivepreventive actioninternal quality auditorcontinuous improvement facilitationquality management systemquality auditchange controlcorrectivepreventive action capa

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