Job
Core
QA Operations Scientist ensuring GMP compliance, operational readiness, and quality standards in pharmaceutical manufacturing.
Role type
Quality Assurance Operations Scientist
Builds
Pharmaceutical products under GMP regulations
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
GMP compliance, deviation investigation, CAPA management, change control, risk assessment, quality metrics analysis, on-floor GMP oversight
Preferred skills
eQMS experience, APQR contribution, mentoring on GMP
Technologies
eQMS
Responsibilities
Own GMP documentation (SOPs, protocols, reports), lead investigations into deviations/OOS/results, manage Change Controls and CAPAs, support audits and inspections, conduct quality risk assessments, investigate customer complaints and temperature excursions, analyze quality metrics, provide on-floor GMP oversight, contribute to APQRs and quality reviews, mentor colleagues on GMP requirements
Seniority
Mid-level, hands-on IC
