Baxter Hiring for Research Assoc I, Product Quality at Ahmedabad, Gujarat, India Full Time

Job Description

This is where you save and sustain lives At 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 patients. Baxter’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 work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

• Newly absorbed incremental Product Quality activities to support the new R&D Facility
• Review and approval of all ADL/F&D/Characterization Instrument and equipment’s qualification/preventive maintenances and calibration documents.
• Separate documentation cell management, which is not in system currently.
• Maintenance of laboratory licenses like DSIR etc.
• Management of multiple laboratory agreements.
• Increased compliance assessment of R&D laboratories (GEMBA walk throughs, Quality spot checks, etc.)
• SPOC for all IT tools assessment and implementation in AMD R&D, as continual compliance system improvement,
• Assessment of CSV and other software related requirements.
• Responsible for implementation of various IT tools.

To review and approve QMS documents like change controls, Non-conformance Report (NCR), Corrective action & Preventive action (CAPA) etc.

• To handle and monitor the Analytical software as an Admin role.
• To review qualification documents (IQ, OQ, PQ) of instruments and equipment and verify internal and external calibration records as and when required.
• Implement new or improved techniques and procedures around specific tasks; Prepare, review and implement SOP. Implement better and compliant quality systems
• In addition to having in-depth knowledge and understanding of cGxP and related regulations and guidance, to provide expert advice and/or is an active participant in the generation, review, adoption, and interpretation of such regulations.
• To carry out internal quality audits of R&D lab & maintain Good Laboratory practices by regular GEMBA walks.
• To devise, upgrade & implement quality systems for F&D (Formulation & Development) and ADL (Analytical Development Laboratory) & Characterization
• To verify Calibration Master Schedule and Preventive maintenance schedule. Ensure compliance for internal and external calibration and Qualification status of Instruments/Equipment.
• Coordinate with various Global SMEs, User departments to resolve all the queries related to global tools like ELN, TCU, track wise, CFS, and Compliance builder to make a Quality system more compliant.

Reasonable Accommodations Baxter 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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information. Recruitment Fraud Notice

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