Tech, Metrology & Qualification

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou 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 softwares.

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 equipments Scheduling of Calibration & Maintenance Execution of Calibrations (by vendors) Review & approval of Calibration/Maintenance documents Retirement of equipments Initiating OOTs/UOOTs

- Preparing and maintaining Validation Master Plan for periodic re-qualification of equipments.

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 SOPs & 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 SOPs.

Strong team player interpersonal soft skills communication & organizational skills.

Knowledge & experienced in MS-Office tools.

Fluency in English - communication Speaking & writing.

Education and Experience: -

Bachelors 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

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