CAPA & Quality Operations Specialist (Pharmacovigilance)
Core
Lead and coordinate Non-Conformance (NC), Corrective and Preventive Action (CAPA), and Quality Issue management to ensure compliance with global quality standards and maintain audit readiness.
Role type
Senior IC Quality Operations Specialist (Pharmacovigilance)
Builds
Quality management processes and audit-ready documentation for Life Sciences/Medical Safety operations
Domain
Life Sciences / Pharmacovigilance / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CAPA management, Root Cause Analysis, GxP compliance, Quality Investigation, Non-Conformance management, SOP development, audit support, metrics reporting
Preferred skills
Global pharmaceutical/biotech experience, eQMS platform usage, Medical Safety organization experience
Technologies
eQMS, CAPA management platforms
Responsibilities
Own and manage NC, QI, CAPA, and Correction records; Lead quality investigations and facilitate Root Cause Analysis; Monitor CAPA/NC records for timely closure; Generate quality performance reports; Support audit and inspection preparedness; Contribute to SOP and process improvement initiatives
Seniority
Senior, hands-on IC
