Site Self Inspection Lead, Quality Assurance - 1st Shift
Core
Lead site self-inspections, manage inspection plans, evaluate CAPAs, and support site inspection readiness for pharmaceutical manufacturing facilities.
Role type
Senior Quality Assurance Lead (Site Self-Inspection)
Builds
Site quality systems and compliance readiness
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Pharmaceutical cGMP knowledge, Global GMP evaluation, CAPA management, Audit planning and execution, Regulatory compliance (FDA/EMA/WHO/ISO), Trend analysis, Training and coaching
Preferred skills
None stated
Technologies
None stated
Responsibilities
Create and track site self-inspection plans and agendas; Lead and participate in site self-inspections and facility walkthroughs; Evaluate and track CAPA items and verify effectiveness; Prepare annual trend reports and facilitate bi-monthly reviews; Support site Inspection Readiness Plan and Board of Health inspections; Perform external audits of third-party suppliers; Participate in global operations audits and training.
Seniority
Senior, hands-on IC
