Quality Assurance Specialist-Third-Party laboratory
Core
Provide commercial quality support and manage third-party laboratories conducting post-importation testing for pharmaceutical products, medical devices, biologics, and cosmetics.
Role type
Quality Assurance Specialist (Third-Party Laboratory Management)
Builds
Compliance with local and corporate quality regulations for drugs, biologics, devices, and cosmetics.
Domain
Pharmaceutical Quality Assurance / Regulatory Compliance
Deliverable
client delivery
Required skills
Quality system design, GxP compliance, supplier qualification, audit coordination, change control management, risk assessment, cold chain monitoring, deviation investigation, reference standard management.
Preferred skills
SAP, Track Wise, ComplianceWire, One Vault familiarity, local GxP regulations knowledge.
Technologies
SAP, Track Wise, ComplianceWire, One Vault
Responsibilities
Manage third-party laboratory contracts and performance metrics; ensure compliance with Good Storage and Distribution Practices; coordinate internal and external audits; investigate quality events and deviations; manage change controls and method communications; maintain supplier qualification records; ensure timely provision of reference standards and reagents.
Seniority
Individual Contributor, tactical execution with independent task management