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\xe2\x80\x94where your purpose accelerates our mission.

• Must have worked in core pharmaceutical manufacturing organization
• Having strong understanding of 21 CFR Part 11, EU Annex 11 & other regulatory guidelines. Clear understanding of Electronic Records, Electronic Signature and Data Integrity principles
• Must have worked in USFDA, MHRA approved plants. Well versed with regulatory expectations from CSV and IT compliance aspects
• Must have faced regulatory audits such as USFDA, ANVISA, MHRA, WHO etc.
• Must have understanding of software development life cycle
• Perform computerized system validation for Manufacturing and laboratory software applications. To maintain systems in a validated state.
• Perform Infrastructure Qualification
• Must have worked on application validation of BMS/EMS, Water systems and other utility applications
• Must have sound knowledge on PLC/SCADA based systems and qualification procedure and test cases
• Prepare, review and approve validation deliverables in line with the SOP and execute qualification protocol and test scripts
• To administer the laboratory computerized systems which includes but not limited to user access management, periodic review, user list preparation etc.
• Managing stakeholder, prioritize projects as per the business needs and follow due timelines for any assigned project and have ability to communicate with global and leadership team.
• Participation in vendor assessment and FAT on requirement basis
• To participate and support in internal and external audits and preparing response on the observations.

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.

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Baxter