QA Validation Specialist 3
Core
Reviewing, approving, and overseeing validation and qualification activities for equipment, facilities, utilities, and processes in a GMP-regulated pharmaceutical environment.
Role type
Senior QA Validation Specialist
Builds
Validated equipment, facilities, and processes for pharmaceutical and life sciences products
Domain
Pharmaceutical / Life Sciences / Quality Assurance
Required skills
GMP/GxP compliance, validation methodologies (DQ/IQ/OQ/PQ), risk assessment, deviation/CAPA/change control management, lifecycle documentation management, impact assessment, stakeholder collaboration
Preferred skills
Process optimization, continuous improvement, independent ownership, multidisciplinary team collaboration
Technologies
GAMP, GMP, GDP
Responsibilities
Review and approve validation documentation (DQ, IQ, OQ, PQ), assess and approve User Requirement Specifications (URS), prepare and maintain validation plans, perform risk assessments for equipment and facilities, approve FAT/SAT/commissioning reports, manage deviations and change controls, conduct periodic reviews of validated systems, support production departments with validation activities
Seniority
Senior, hands-on IC
