Quality Assurance Officer
Core
Ensuring compliance to cGMP requirements through real-time quality support, batch record reviews, and operational audits in a manufacturing environment.
Role type
Quality Assurance Officer (GMP)
Builds
Pharmaceutical/biotech products ensuring safety and regulatory compliance
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality Assurance in manufacturing)
Required skills
cGMP knowledge, batch record review, deviation investigation, process validation review, internal auditing, risk assessment, SOP updating
Preferred skills
Quality Assurance experience in GMP environment, biotechnology/biochemistry background
Technologies
GMP systems, Quality Management System (QMS)
Responsibilities
Perform real-time batch record reviews and audits of logbooks, approve batch documentation and quality records (deviations, CAPAs), conduct internal audits and risk assessments, update SOPs, serve as a resource for operational areas on quality issues
Seniority
Mid-level, hands-on IC
