Validations Business Analyst
Location: Remote, India
Job ID: R-01336667
Employment Type: Full-Time
Category: Operations
Work Mode: Fully Remote
Work Schedule: Standard (Monday to Friday)
About the Role
A global life sciences organization is seeking a Validations Business Analyst to support and lead validation activities for regulated software systems within a rapidly evolving Global IT and Contact Center environment. This role plays a critical part in ensuring compliant, reliable, and high-quality technology solutions that support Risk Evaluation and Mitigation Strategy (REMS) programs built on Salesforce Health Cloud and Life Sciences platforms.
The position offers the opportunity to collaborate with cross-functional global teams, internal stakeholders, and external clients while contributing to technology initiatives that directly support patient safety, regulatory compliance, and operational excellence.
Key Responsibilities
Provide business and system-level support for validated software applications in regulated environments
Lead and facilitate computer system validation (CSV) activities in alignment with SOPs, regulatory requirements, and client expectations
Support validation for new system implementations, enhancements, and upgrades across the software development life cycle (SDLC)
Prepare and execute validation documentation, including validation plans, test scripts, test cases, and validation summary reports
Ensure test scripts adequately challenge functional requirements and demonstrate system fitness for intended use
Execute test cases accurately and generate compliant evidence to confirm system reliability and performance
Review and approve change controls, performance qualification (PQ), and validation documentation in accordance with SOPs
Participate as a validation representative in project meetings and complete assigned deliverables on schedule
Collaborate with leadership to address validation findings arising from internal audits, client audits, or regulatory inspections
Assist in gathering and reviewing user requirements, functional specifications, and system design documentation
Maintain familiarity with applicable regulations, sponsor requirements, contractual obligations, and internal procedures
Manage multiple assignments concurrently while meeting quality standards and project timelines
Education Requirements
Bachelor’s degree or equivalent formal academic or vocational qualification
Equivalent combinations of education, training, and relevant experience may be considered
Experience Requirements
Minimum 2+ years of relevant experience in business analysis, computer system validation, or regulated IT environments
Experience supporting validated systems within life sciences, healthcare, pharmaceutical, or regulated technology domains is preferred
Required Skills and Competencies
Strong understanding of computer system validation principles and the software development life cycle (SDLC)
Solid knowledge of life sciences operational processes, terminology, and regulatory expectations
Excellent attention to detail with strong analytical and problem-solving abilities
Ability to prepare, review, and critique SDLC documentation, including requirements, design specifications, and test plans
Demonstrated troubleshooting skills to analyze software defects and test failures
Strong customer focus with effective written, verbal, and interpersonal communication skills
Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Project
Ability to learn new systems and software with minimal guidance
Strong organizational and time management skills with the ability to adapt to changing priorities
Ability to work independently while managing multiple tasks under tight deadlines
Proven ability to collaborate effectively with cross-functional and multidisciplinary teams
Work Environment and Expectations
Fully remote role with flexibility to support global project teams
Work hours may vary based on project needs and deliverables
Ability to perform under pressure and manage multiple concurrent activities
Regular and reliable attendance is required
Why Join This Organization
The organization’s Operations and IT teams play a vital role in delivering life-saving medicines, laboratory solutions, and next-generation technologies worldwide. Employees are supported by a culture of continuous improvement, innovation, and collaboration, driven by a strong commitment to quality, compliance, and customer success.
Equal Employment Opportunity
The organization is an Equal Opportunity Employer and is committed to creating an inclusive and accessible workplace. All qualified applicants will receive consideration for employment without discrimination based on legally protected characteristics.
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