Sr. QA Validation Specialist
Core
Oversee qualification and validation activities for equipment, facilities, and utilities to ensure compliance with quality and regulatory standards in medicine manufacturing.
Role type
Senior QA Validation Specialist
Builds
Validated equipment, facilities, and utilities for medicine production
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
Validation methodologies (DQ, IQ, OQ, PQ), cGMP, GxP, GAMP, regulatory compliance (EU/FDA), analytical problem-solving, documentation review
Preferred skills
Continuous improvement, standardization of processes, cross-functional collaboration
Technologies
Validation lifecycle tools, GAMP-compliant systems
Responsibilities
Oversee qualification and validation activities for equipment, facilities and utilities; Review and approve validation documentation; Ensure traceability of requirements throughout the validation lifecycle; Assess validation impact and support periodic reviews; Manage validation deviations and changes; Provide quality and compliance support to Engineering and Manufacturing teams
Seniority
Senior, hands-on IC
