Senior Specialist II Quality Assurance
Core
Senior Quality Assurance Specialist responsible for shop floor quality management, major quality issue investigation, product release, and GMP compliance.
Role type
Senior Specialist II Quality Assurance (Pharmaceutical)
Builds
Pharmaceutical products ensuring GMP compliance and quality standards
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
GMP knowledge, Quality system management, Quality risk management, Process control methodology, Statistics (Cpk, FMEA), SAP/Microsoft applications, English proficiency
Preferred skills
8+ years QA experience, Multi-national enterprise experience, Cross-functional experience
Technologies
SAP, Microsoft applications
Responsibilities
Identify and resolve daily shop floor quality risks, Lead investigation of major/critical quality issues, Approve minor deviations, Release products, Support PET business processes for compliance, Conduct regulatory inspections and self-inspections, Draft and approve GMP documents, Manage QA team daily operations and performance, Address SHE risk factors
Seniority
Senior, hands-on IC with team management