Senior Specialist Quality Assurance
Core
Senior QA Specialist responsible for shop floor quality management, leading major quality issue investigations, product release decisions, and GMP compliance.
Role type
Senior Specialist Quality Assurance (Pharmaceutical)
Builds
Production quality compliance and safety
Domain
Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality release & shop floor management)
Required skills
GMP knowledge, Quality risk management, Process control methodology, Statistics (Cpk, FMEA), SAP, English fluency
Preferred skills
Cross-functional experience, Multi-national enterprise experience
Technologies
SAP
Responsibilities
Identify and resolve daily shop floor quality risks; Lead investigation and assessment of major/critical quality issues; Approve minor deviations; Draft, review, and approve GMP documents; Manage QAF/Site procedures; Lead team projects and cross-functional improvement initiatives; Coordinate regulatory and global audits; Manage and mentor QA team members.
Seniority
Senior, hands-on IC with team management