QA Specialist
Core
Manage QA systems and execute QA duties for batch release in a pharmaceutical manufacturing environment.
Role type
QA Specialist (Pharmaceutical Manufacturing)
Builds
X-ray and MRI contrast media
Domain
Healthcare / Pharmaceutical Manufacturing
Required skills
GMP compliance, Quality Management System (QMS) management, batch release coordination, root cause analysis, CAPA implementation, regulatory documentation management, change control, cross-functional collaboration
Preferred skills
Continuous improvement, risk-based decision making, troubleshooting, stakeholder negotiation
Technologies
GMP, QMS, SOPs, validation protocols
Responsibilities
Ensure compliance with GMP and regulatory requirements; coordinate and execute QA duties for QP batch release; lead root cause investigations and CAPA actions; author and manage quality documentation (SOPs, change controls, batch release docs); partner with stakeholders to deliver activities on time; support cross-functional continuous improvement teams.
Seniority
Mid-level, hands-on IC
