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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Job Responsibility:
Part of R&D Tech, Metrology & Qualification team
Responsible for end-to-end Calibration Asset lifecycle management through BMRAM tool
Supporting the users/instrument owners for Qualification & Validations for new installation of laboratory instruments & existing re-qualifications
Participating in the external/Internal audits for M&Q
SOP Management for M&Q
Complying to the Quality as per the QMS requirements for M&Q activities
Supporting CFT team for CSV for user privileges in application software’s
End-to-end vendor management for Calibration/Maintenance/Qualification services
Responsible for the following in BMRAM tool: Registration of new equipment's, Scheduling of Calibration & Maintenance, Execution of Calibrations (by vendors), Review & approval of Calibration/Maintenance documents, Retirement of equipment's, Initiating OOTs/UOOTs - Preparing and maintaining Validation Master Plan for periodic re-qualification of equipment's
Co-ordinating between CFT including Users/Equipment owners, Quality & Vendors for on time completion of Calibrations/Maintenance
Getting the approval of the PO from various Business Units for Calibration/Maintenance
Responsible for Review and finalizing of Calibration Quotations, AMC and CMC for instruments and coordination of vendor/ Service provider to completion Metrology activities
Reviewing and approving the Qualification & Validations documents for new installation of laboratory instruments
Adhering to Quality Management Systems such as NCR & CAPA management, Change Management
Participating as M&Q representatives in internal/external audits
Writing technical documents such as SOP, Protocols, Test scripts, Assessment reports
Participating in review of global SOP’s & procedures
Ensuring adherence to GxP as per QMS requirement
Requirements:
Well versed with GxP and National Standards, NABL requirements, Regulatory requirements in terms of Calibration & Maintenance
Strong interpersonal skills and demonstrated ability to work in team environment
Strong technical skills in terms of Calibration, Maintenance, Qualifications, Vendor Management, Quality Systems
Strong skills in terms of writing, reviewing & approving GMP documents such as protocols, tests, SOP's
Strong team player, interpersonal, soft skills, communication & organizational skills
Knowledge & experienced in MS-Office tools
Fluency in English - communication, Speaking & writing
Bachelor's degree in Instrumentation & electronics or Equivalent
Minimum 2-6 years’ experience in Calibration/Maintenance/Qualifications for Pharma or Medical device industry