Lead Auditing QA Specialist
Core
Lead planning and execution of audits for products and processes to ensure GMP compliance and quality in pharmaceutical manufacturing.
Role type
Senior IC Lead Auditing QA Specialist
Builds
Audit plans, evidence-based audit reports, corrective and preventive action plans
Domain
Pharmaceutical manufacturing / Quality Assurance / GMP compliance
Required skills
GMP regulations knowledge, audit planning, risk identification, root cause analysis, SOP development, cross-functional collaboration, training and mentoring
Preferred skills
Science degree, experience in pharma or biotech manufacturing operations
Technologies
None stated
Responsibilities
Lead audits of products and processes, conduct opening and closing meetings, develop audit plans, select audit teams, lead interviews with key personnel, represent the company in external audits, identify areas for improvement, train junior auditors, participate in investigations into product safety and quality issues
Seniority
Senior, hands-on IC with leadership responsibilities
