Business Analyst
Job SummaryWe are seeking an experienced Business Analyst (BA) with a strong background in Life Sciences / Biopharma / Drug Manufacturing and proven experience working with IT teams to translate business needs into clear functional and technical requirements.The ideal candidate will act as a bridge between business stakeholders (Manufacturing, QA, R&D) and IT teams, ensuring solutions align with regulatory requirements and business objectives in a GxP-compliant environment.Key ResponsibilitiesBusiness & Domain AnalysisCollaborate with stakeholders across Manufacturing, Quality, Supply Chain, and R&D to understand business processes and challengesAnalyze and document workflows related to:Drug manufacturing (batch processes, MES, LIMS)Quality processes (Deviation, CAPA, Change Control)Ensure all requirements comply with GxP, FDA, and regulatory standardsRequirement Gathering & DocumentationElicit, analyze, and document requirements using:BRD (Business Requirement Documents)FRD (Functional Requirement Documents)User stories and acceptance criteriaCreate process flows, use cases, and data flow diagramsPerform gap analysis and impact assessmentBusiness to IT TranslationTranslate business requirements into:Functional specificationsTechnical requirements (in collaboration with architects/dev teams)Define system behavior, integration points, and data requirementsSupport design discussions with technical teams and solution architectsTechnology & Integration SupportWork closely with IT teams on:APIs (REST/SOAP), system integrations, middlewareEnterprise systems (e.g., SAP, MES, LIMS, Veeva, TrackWise)Document:Interface specificationsData mapping and transformation logicTesting & ValidationSupport UAT planning and executionDevelop test scenarios, test cases, and traceability matrices (RTM)Ensure systems meet compliance and validation requirements (CSV/CSA)Participate in audits and validation documentation (URS, IQ/OQ/PQ)Stakeholder ManagementAct as a liaison between:Business users (non-technical)IT and development teamsFacilitate workshops, requirement sessions, and solution reviewsCommunicate complex technical concepts in a simple, business-friendly mannerRequired QualificationsEducationBachelor’s or Master’s degree in:Life Sciences / Pharmacy / BiotechnologyComputer Science / Engineering (with domain experience)Experience5+ years of experience as a Business AnalystStrong experience in Life Sciences / Biopharma / Pharma manufacturing domainProven experience working with IT delivery teamsDomain KnowledgeUnderstanding of:Drug manufacturing processesGxP (GMP, GCP, GLP) environmentsRegulatory frameworks (FDA, EMA, 21 CFR Part 11)Familiarity with:QMS systems (Deviation, CAPA, Change Control)Validation processes (CSV / CSA)Technical SkillsGood understanding of:APIs, integrations, and system architecturesData modeling and basic SQL conceptsExperience with enterprise systems:SAP, MES (e.g., Werum PAS-X), LIMS, Veeva, TrackWiseTools:JIRA / Azure DevOpsConfluenceVisio / LucidchartCore BA SkillsStrong requirement elicitation and documentation skillsExperience with Agile and/or Waterfall methodologiesAbility to create:Process flows (BPMN/UML)Functional specificationsUser stories and acceptance criteriaPreferred QualificationsExperience in serialization / track & trace (DSCSA, EU FMD)Exposure to cloud platforms (Azure / AWS)Knowledge of pharmacovigilance or clinical systemsBA certifications (CBAP, PMI-PBA)Key CompetenciesStrong analytical and problem-solving skillsExcellent communication and stakeholder managementAbility to bridge business and technical teams effectivelyAttention to detail in regulated environmentsAdaptability in fast-paced project environments