Validations Business Analyst – Life Sciences IT
Location: Fully Remote – India
Job Type: Full-Time
Job ID: R-01335765
Category: Operations / Information Technology
Work Schedule: Standard (Monday to Friday)
About the Organization
Customers worldwide rely on our extensive portfolio of products and services, ranging from life-saving medicines and laboratory essentials to next-generation scientific instruments. Our Operations and Global IT teams play a vital role in delivering these solutions by leveraging the Practical Process Improvement (PPI) Business System to continuously enhance quality, compliance, and productivity. Together, we support a mission-driven organization dedicated to making the world healthier, cleaner, and safer.
Role Overview
The Validations Business Analyst will support and lead system validation initiatives for regulated life sciences technology platforms, including Salesforce Health Cloud and Life Sciences solutions supporting Risk Evaluation and Mitigation Strategy (REMS) programs. This role involves close collaboration with global, cross-functional stakeholders to ensure validated systems meet regulatory, quality, and business requirements throughout the software development lifecycle (SDLC).
This position is ideal for professionals with experience in computer system validation (CSV), life sciences IT, and business analysis who are seeking to contribute to high-impact, compliance-driven technology programs in a fully remote environment.
Key Responsibilities
Provide business and system support for validated software applications within a regulated life sciences environment.
Lead and support computer system validation activities, including system upgrades, enhancements, and new application releases.
Prepare and execute validation documentation, including validation plans, test scripts, test cases, and validation summary reports.
Participate as a validation representative in project team meetings and complete assigned deliverables within agreed timelines.
Review and approve change controls, performance qualification (PQ) documentation, and validation artifacts in accordance with SOPs.
Ensure test scripts adequately challenge functional requirements and demonstrate that systems consistently perform as intended.
Execute test scripts accurately, generating traceable evidence of system reliability, accuracy, and compliance.
Support internal and client audits by identifying, investigating, and resolving validation-related findings.
Collaborate with business users, developers, and quality teams to define user requirements and support system design documentation.
Review and critique SDLC documentation, including requirements specifications, functional designs, system designs, and test plans.
Manage multiple assignments simultaneously while meeting quality, regulatory, and contractual expectations.
Build productive working relationships with internal teams and external customers or vendors.
Experience and Qualifications Required
Bachelor’s degree or equivalent formal academic or vocational qualification in Information Technology, Life Sciences, or a related discipline.
Minimum 2+ years of relevant experience in business analysis, computer system validation, or regulated life sciences IT environments.
Working knowledge of software development life cycle (SDLC) and validation methodologies.
Experience supporting or validating systems used in regulated environments such as pharmaceutical, biotech, or healthcare.
Strong understanding of life sciences operational processes, regulatory expectations, and SOP-driven environments.
Demonstrated proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Project.
Strong analytical, troubleshooting, and problem-solving skills with high attention to detail.
Excellent written and verbal communication skills, with the ability to guide stakeholders and document technical processes clearly.
Proven ability to manage changing priorities, multiple deliverables, and tight deadlines in a fast-paced environment.
Ability to work independently with minimal supervision while collaborating effectively with cross-functional teams.
Preferred Skills and Attributes
Experience supporting or validating Salesforce Health Cloud or Life Sciences platforms.
Familiarity with REMS programs and regulated patient safety systems.
Experience participating in or supporting regulatory inspections and audits.
Strong organizational skills with the ability to perform under pressure and manage variable workloads.
Why Join This Opportunity
Fully remote role with global exposure to regulated life sciences IT programs.
Opportunity to work on high-impact REMS and patient safety initiatives.
Collaborative, quality-focused culture within a global operations and IT organization.
Long-term career growth in validation, compliance, and digital transformation initiatives.
How to Apply
Qualified professionals with experience in system validation and business analysis are encouraged to apply through the official careers portal. Applications are reviewed on a rolling basis.
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