GMP Operational Quality Senior Specialist
Core
Supports GMP operational quality assurance and regulatory compliance, executing investigations, change controls, and continuous improvement in a pharmaceutical setting.
Role type
Senior IC GMP Operational Quality Specialist
Builds
Quality oversight for investigations, CAPA actions, and change control implementations
Domain
Pharmaceutical manufacturing / cGMP
Required skills
Root Cause Analysis (RCA), CAPA management, change control assessment, cGMP knowledge, cross-functional collaboration, project support
Preferred skills
None stated
Technologies
None stated
Responsibilities
Support root-cause analysis and product impact assessment for deviations/OOS/OOT investigations; Support change control assessments, implementation, and closure; Identify and facilitate continuous improvement efforts; Support drafting and revising Quality Agreements with CMOs/Suppliers
Seniority
Mid-level, hands-on IC
