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Sr Assoc, QA - IPQA Production

4.00 to 5.00 Years   Ahmedabad   09 Apr, 2021
Baxter India
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

Sr Assoc, QA - IPQA ProductionApply 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 ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and all
  • In Process Quality Assurance Activities i.e Line Clearance, In-Process Sampling, FP Sampling, Shop Floor Compliance, Quality Risk Assessment, Quality Management system i.e Incident, Investigations, CAPA, Change Control.
  • To take instructions from shift in-charge daily and report the activity done, shift wise to Shift in-charge.
  • 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 raise request for stability batch destruction after expiry period is over.
  • To receive and handle data loggers and to place the data loggers in consignment at the time of shipment.
  • To carry out reconciliation and physical verification of the returned goods.
  • To verify headspace oxygen and dissolve oxygen during in-process monitoring.
  • To verify logbooks, online documents, records, analysis report and other supporting documents related to products manufactured in the plant.
  • To provide support to shift in-charge and Section Head in investigation, in case of any product complaints or deviation.
  • To execute the Corrective and Preventive Action (CAPA) defined by Quality Management System (QMS), as per instruction of Executive.
  • To verify secondary packing material at the time of issuance against Technical Package / Standard Material Requirement Form and approve the process step.
  • To execute line clearance for routine packing activity, monitor each packing line at regular time interval and sample collection.
  • To support in trend analysis of the packing line monitoring and keep track of Out of Trend (OOT) results and report to Sub-department Manager.
  • To execute the CAPA defined by QMS and as per instruction of Sub-department Manager.
  • To give non-compliance reports to the respective departments in case of internal quality audits and report it to Section Head and Department Head.
Preferred Educational Qualification: M Pharm, MSc, B Pharm, Bio Tech Graduates/Post Graduates 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.Apply Now Save Job,

Keyskills :
correctivepreventive actioninternal quality auditorcontinuous improvement facilitationquality management systemshop floorquality audittrend analysisprocess qualityrisk assessmentcorrectivepreventive action capa

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