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
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
