IS Bus Sys Analyst

What you will do

Lets do this. Lets change the world. In this vital role you will play a key role in bridging the gap between business processes and information technology. They are responsible for analyzing business needs, gathering and documenting requirements, creating detailed business analysis, outlining problems, and ensuring the alignment of IT strategies with business goals.

The IS Business Analyst will work closely with collaborators, IS teams, and end-users to understand their requirements, analyze risks and create and prepare documentation.

Roles & Responsibilities:

The IS Business Analyst at Amgen India will lead requirement gathering sessions, document business processes, and create SDLC work for review. Key responsibilities include:

• Assist in testing preparation, testing, and validation
• Collaborate with collaborators to identify and document business needs and validation requirements
• Provide appropriate functional support throughout the life of the projects/products
• Serve as the main point of contact between business collaborators and technical teams during validation processes.
• Create and maintain comprehensive documentation, including requirement specifications, SOPs, manuals, validation protocols, and test cases
• Create detailed process maps and workflows to visualize current and future state processes.
• Develop change management plans and communication strategies to facilitate smooth transitions
• Train new employees on IT procedures and ensure compliance with standards
• Monitor and address any validation-related issues that arise during project execution.
• This position may have after hours responsibilities

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Masters degree and 2 years of Information Systems experience or related field OR
• Bachelors degree and 4 years of Information Systems experience or related field OR
• Associates degree and 6 years of Information Systems experience or related field OR
• High school diploma / GED and 8 years of Information Systems experience

Must-Have Skills:

• Proficient in eliciting, documenting, and managing requirements through various techniques (interviews, workshops, surveys).
• Meticulous in reviewing documentation, requirements, and validation results to ensure accuracy and compliance.
• Knowledge of documentation practices and standards required for regulatory submissions and audits.
• Experience with systems in a federally regulated environment - FDA/SOX
• Skills to identify, engage, and manage collaborators effectively throughout the project lifecycle.
• Basic project management skills to help manage timelines, resources, and collaborator expectations
• Flexibility to adapt to changing business needs, priorities, and technologies.
• Sharp learning agility, problem-solving and analytical thinking

Good-to-Have Skills:

• Familiarity with GxP, CFR 21 Part 11 and systems validation
• Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ))
• Experience with testing and validation tools, and testing frameworks
• Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies

Professional Certifications:

• Certified Business Analysis Professional (CBAP) (preferred)
• PMP Certification (preferred)

Soft Skills:

• Excellent analytical and troubleshooting skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully
• Good social and collaboration skills, with the ability to communicate effectively with business users, technical IT groups, project managers

Work Hours:

• This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours, including weekends and holidays as required.