Job Description
We are seeking an experienced Technical Business Analyst with experience. The successful candidate will act as a bridge between business stakeholders, IT, and Quality Assurance teams to ensure transparent requirements gathering, technical documentation, and compliance with regulatory standards.
Key Responsibilities
Elicit, analyze, document, and manage business and technical requirements including User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
Review and interpret technical artefacts such as code snippets, workflows or pseudocode to align business needs with technical solutions.
Collaborate closely with cross-functional teams including IT, Quality Assurance, and business units to clarify requirements, address gaps, and facilitate smooth solution delivery.
Ensure compliance with pharmaceutical regulations and standards including Good Practice (GxP) and Computer System Validation (CSV) processes.
Support testing activities including test case development, execution, defect triage, and validation documentation.
Utilize project management and requirement tracking tools such as ALM and JIRA to manage requirement lifecycle and maintain traceability.
Identify and recommend opportunities for process improvements and support strategic technology initiatives, including AI integration where applicable.
Facilitate workshops and stakeholder meetings to gather requirements and resolve issues proactively.
Manage controlled documentation updates to ensure alignment with compliance and audit readiness.
Required Skills & Qualifications
Minimum 6 years’ experience as a Business Analyst in the pharmaceutical or life sciences industry.
Robust understanding of GxP regulations and Computer System Validation (CSV) in pharmaceutical settings.
Experience with Veeva Vault systems and/or other regulated cont