Analyst, Information Technology

Mployee.me; Bengaluru; Vor Ort; INR 1.500.000 - 2.600.000; Vollzeit

Zusammenfassung

Baxter is seeking a seasoned Business Analyst to join the Global IT Function, bridging business needs with technology across Medical, Quality, Regulatory and Supply Chain in a medical device setting.

You will translate complex problems into structured requirements, validate solutions, and partner with cross‑functional teams to ensure compliant, scalable outcomes aligned with FDA, GxP, and ISO standards.

Qualifikationen

• Bachelor's degree in Engineering, CS, Data Analytics or related field.
• 6–10+ years' experience as BA, Product Owner, Data Analyst, or similar.
• Experience in regulated life sciences/medical devices or healthcare.
• Experience with validation and GxP applications (e.g., Veeva RIM, Veeva PromoMats).
• Strong ability to translate complex business needs into structured requirements and stories.
• Excellent communication and stakeholder management.

Aufgaben

• Partner with leaders to identify high-value improvements in regulatory affairs, patient safety, process optimization, product quality, complaint analytics and regulatory intelligence.
• Conduct feasibility assessments and prioritization of user stories.
• Stay current on emerging regulatory developments and industry best practices within regulated healthcare environments.
• Lead detailed discovery sessions to understand business workflows, data sources, constraints and pain points.
• Translate business needs into clear functional requirements for technical and vendor partners.
• Map current-state and future-state processes to identify automation and optimization opportunities.
• Review and analyze user requirements prior to submission and implementation; participate in validation activities as required.
• Ensure solutions comply with company Quality Management Systems (QMS) requirements, Good Automated Manufacturing Practice (GAMP 5), 21 Code of Federal Regulations (CFR) Part 11 regulations.
• Support the creation, review, and execution of validation deliverables, including Validation Plans, Risk Assessments, Risk Management Reports, Traceability Matrices, Validation Reports, User Acceptance Testing (UAT), and Regression Testing activities.
• Partner with QA / RA / Business teams to implement configuration and perform validation execution.
• Develop user stories, Formal Requirements, UAT scripts, test cases, test plans and training materials.
• Lead UAT cycles, gather feedback and ensure readiness for go-live.
• Drive adoption through ongoing user engagement, training and performance monitoring.
• Understand, follow and implement appropriate Software Development Life Cycle (SDLC), computer system validation, quality validation processes and application lifecycle processes including those specific to AI project lifecycles.

Kenntnisse

Business Analysis

Stakeholder Management

Requirements Gathering

Validation

Regulatory Compliance

Data Analytics

Communication Skills

Ausbildung

Bachelor's degree in Engineering / Computer Science / Data Analytics

Tools

Veeva RIM

Veeva PromoMats

Jobbeschreibung

This is whereyour 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.

Your Role at Baxter

As a member of the Global IT Function, you as Business Analyst plays a critical role in identifying, designing, and delivering technology solutions that optimize business processes across Medical, Quality, Regulatory, Supply Chain functions within a medical device organization. This role bridges business strategy, data science and technology execution, ensuring technology initiatives are compliant, scalable and aligned with the company’s digital transformation roadmap and regulatory requirements Food and Drug Administration (FDA), ISO 13485, Good "X" Practice (GxP).

This individual partners closely with cross‑functional teams to translate complex business problems into a configurable solution, define data and process requirements, support solution development, manage validation needs and measure impact.

What You'll Be Doing

• Partner with business leaders to identify high‑value improvement opportunities in areas such as regulatory affairs, patient safety, process optimization, product quality, complaint analytics and regulatory intelligence.
• Conduct feasibility assessments and prioritization of user stories.
• Stay current on emerging regulatory developments and industry best practices within regulated healthcare environments.
• Lead detailed discovery sessions to understand business workflows, data sources, constraints and pain points.
• Translate business needs into clear functional requirements for technical and vendor partners.
• Map current‑state and future‑state processes to identify automation and optimization opportunities.
• Review and analyze user requirements prior to submission and implementation; participate in validation activities as required.
• Ensure solutions comply with company Quality Management Systems (QMS) requirements, Good Automated Manufacturing Practice (GAMP 5), 21 Code of Federal Regulations (CFR) Part 11 regulations.
• Support the creation, review, and execution of validation deliverables, including Validation Plans, Risk Assessments, Risk Management Reports, Traceability Matrices, Validation Reports, User Acceptance Testing (UAT), and Regression Testing activities.
• Partner with QA / RA / Business teams to implement configuration and perform validation execution.
• Develop user stories, Formal Requirements, UAT scripts, test cases, test plans and training materials.
• Lead UAT cycles, gather feedback and ensure readiness for go‑live.
• Drive adoption through ongoing user engagement, training and performance monitoring.
• Understand, follow and implement appropriate Software Development Life Cycle (SDLC), computer system validation, quality validation processes and application lifecycle processes including those specific to AI project lifecycles.

What You'll Bring

• Bachelor's degree in Engineering, Computer Science, Data Analytics or related field.
• 6–10+ years of experience as a Business Analyst, Product Owner, Data Analyst or similar role.
• Experience working in a regulated Life science, medical device, pharmaceutical, or healthcare environment.
• Experience working with validation, implementation of GxP applications such as Veeva RIM, Veeva PromoMats, Patient Safety, Medical Systems.
• Strong understanding of computer system validation, computer system assurance processes, analytics workflows and system integrations.
• Ability to translate complex business needs into structured requirements and user stories.
• Excellent communication, facilitation and stakeholder management skills.
• Familiarity with GxP, GAMP 5, 21 CFR Part 11, ISO 13485 and validation principles.

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, and let us know the nature of your request along with your contact information.