Tech, Metrology & Qualification

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Summary: -

·       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.

Strong technical knowledge & technical writing ability.

Essential Duties and Responsibilities: -

·       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.

Qualifications: -

•        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.

Education and Experience: -

·     Bachelor's degree in Instrumentation & electronics or Equivalent.

- Minimum 2-6 years’ experience in Calibration/Maintenance/Qualifications for Pharma or Medical device industry.

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, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter 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.

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