QA Specialist
Core
Ensure compliance with GxP, ISO, and internal quality standards in a GMP-regulated laboratory and manufacturing environment.
Role type
QA Specialist (GxP/ISO compliance)
Builds
High-quality testing services and pharmaceutical products for clients
Domain
Life Sciences / Pharmaceuticals / Contract Testing
Required skills
GxP regulations knowledge, deviation/CAPA/change control management, risk assessment, root cause analysis, data integrity, audit support, process improvement
Preferred skills
Chemistry/Biotechnology background, digitalization/automation experience, mentoring
Technologies
GxP systems, digital QA tools, automated QA solutions
Responsibilities
Review and approve analytical protocols, SOPs, and Certificates of Analysis; Investigate deviations, OOS, and customer complaints; Assist in internal and regulatory audits; Lead process improvement projects; Train and mentor colleagues
Seniority
Mid-level, hands-on IC
