Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Job 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 cycle.

As 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 documents.

Should have good knowledge of Quality Management systems

JobResponsibilities:

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 Opportunity

Baxter 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 characteristic.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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