Tech Metrology Qualification Job In Baxter Medical Devices In Bengaluru / Bangalore, India

This 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 You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patientsBaxter'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 workJoin us at the intersection of saving and sustaining lives-where your purpose accelerates our missionAbout BaxterBaxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis sterile IV solutions infusion systems and devices parenteral nutrition surgery products and anesthetics and pharmacy automation, software and services The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.

Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient careJob Summary Job Title - Tech Metrology & Qualification Location - Whitefield, Bangalore Shift - General The Tech M&Q will work with the cross functional team, stake holders, Quality & vendors to carry out the Calibration & Maintenance activities as well as Qualifications in line with Quality Management Systems.

In this role you are expected to maintain the lifecycle of instruments including the scheduling, maintenance & trouble shooting as per the calibration cycleAs Tech M&Q you are also expected to be part of the Qualifications both internal & external, play the role of Validation representative giving the inputs with respect to Metrology including the reviewing of documentsShould have good knowledge of Quality Management systemsJobResponsibilities:Calibration & Maintenance

• Expertise in Calibration & maintenance wrt to various equipments & Instruments in terms of Medical devices, R&D, Pharma
• Expected to be technically strong in terms of carrying out the calibrations & maintenance as well as supervise the same with 3rd party vendors
• Well aware of the National Standards, NABL requirements, Regulatory requirements in terms of Calibration & Maintenance.
  
  
• Should be well aware of ISO13485 & 172085 in terms of applicability wrt to Metrology
• End to end handling of the calibration & maintenance lifecycle & should be well versed to use the electronic platforms for the same including troubleshooting
• Vendor management - to interact with the suppliers & third parties for completion of calibration activities within the scheduled timelines
• Proactive in organizing the activities as per the schedule by coordinating with stakeholders as well as vendors
• Budgeting & optimizing the Calibration & Maintenance costs.
  
  
• Working on the CAPEX projects & driving the continuous improvement initiatives
• Basic knowledge on environmental monitoring system

Qualification & Validations

• To be well versed & have hands on experience in end to end qualification process ( inhouse & external)
• To be able to review & provide technical inputs for the QP, IQ,OQ,PQ & DQ
• Supporting the users/instrument owners for Qualification & Validations for new installation of laboratory instruments.
  
  

Environmental Monitoring ( EMS )

• Should be familiarized with the Operation & Maintenance of EMS including troubleshooting
• Should be experienced in Temperature Mapping

Other requirements

• Should possess strong skills in terms of writing, reviewing & approving GMP documents such as protocols, tests, SOP's
• Should be well versed with Quality requirements such as NCR & CAPA management with investigations & root cause analysis knowledge, Change Management ( would be an advantage if knows Trackwise tool)
• Should be able to manage the team as well as vendors & stakeholders
• Strong awareness & experience required in GMP, GDP, DI, GLP ( GxP), 21 CFR part 11 compliance.
  
  
• Should have good experience in terms of external & internal audits
• Should know MS-Office tools, software tools such as blue mountain, Trackwise
• Should know the PR/PO & vendor registration process

Educational & Experience

• Experience of 6 - 8 years, educational background preferably BE - Instrumentation or Electronics & instrumentation
• Relevant certifications would be a plus.
  
  
• Good soft skills, communication skills including fluency in English - writing, speaking & communication

Equal Employment OpportunityBaxter is an equal opportunity employer Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristicReasonable 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 and let us know the nature of your request along with your contact information.

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Baxter Medical Devices is looking for .

Baxter Medical Devices is looking for Any Graduate / Post Graduate profile candidates.