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QMS - Business Analyst
Quality & ComplianceHyderabad • Hybrid
QMS BA enables QMS initiatives by eliciting requirements from QA/Quality stakeholders and translating them into URS/FRS, process maps, and user stories across key modules (Deviations, CAPA, Change Control, Complaints, Audits, Document Control, Training). We perform gap assessments, define role-based workflows, data fields, and approval routes aligned to SOPs and regulatory expectations. The BA supports configuration/design reviews, prepares test scenarios, and drives UAT coordination and traceability. The result is a standardized, inspection-ready QMS implementation that improves compliance and operational efficiency.
LIMS BA supports LIMS programs by gathering and analyzing business requirements from QC/QA stakeholders and converting them into URS/FRS, process maps, and user stories. We define end-to-end lab workflows (sample lifecycle, testing, specifications, stability, instruments) and ensure alignment with SOPs, data governance, and compliance expectations. The BA facilitates workshops, gap assessments, and solution design reviews, and coordinates UAT planning and execution. The outcome is a well-defined, testable scope that accelerates delivery and ensures inspection-ready adoption.
Delivers end-to-end validation for regulated systems (LIMS/ELN/MES/QMS and integrations) using a risk-based approach aligned to GAMP and 21 CFR Part 11 / Annex 11 expectations. We support planning and execution across URS/FRS, risk assessment, validation plans, IQ/OQ/PQ, traceability, and test evidence. We also enable compliant change control, periodic review, and deviation/CAPA management to maintain validated state. Our focus is practical, audit-ready documentation and efficient execution without disrupting operations.
Join our marketing team for a summer internship focused on digital marketing and content creation. Gain hands-on
experience in a fast-paced start-up environment.
end-to-end delivery and steady-state support for LabWare environments in regulated QC operations. We develop and enhance LIMS workflows (sample lifecycle, testing, calculations, specifications, stability, instruments), implement configuration changes, and deliver custom scripts/reports where needed. We provide L2/L3 production support with SLA-based incident/problem management, root-cause analysis, and preventive fixes. We also manage upgrades, validation/CSV documentation support, data loads/master data changes, and integrations (instruments, MES, SAP, QMS, DMS) to ensure consistent performance, compliance, and business continuity.
