QA Officer
Core
QA Officer supporting Validation and Engineering teams to ensure regulatory compliance and quality standards in a GMP-regulated environment.
Role type
Quality Assurance Officer (GMP)
Builds
Quality systems, validation protocols, and compliance documentation for pharmaceutical/biotech operations.
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
dashboards & analysis
Required skills
GMP regulations knowledge, deviation investigation, CAPA management, SOP development, risk assessment, document control
Preferred skills
Process validation experience, microbial mapping protocols, resin re-use protocols
Technologies
Quality Management Systems (QMS), GMP documentation tools
Responsibilities
Review and approve equipment and process validation documents; participate in deviation investigations; approve quality records (deviations, CAPAs, audit findings); update SOPs to meet regulatory standards; support compliance timeframes for change controls and investigations; issue protocols to departments; identify continual improvement opportunities; participate in risk assessments.
Seniority
Mid-level, hands-on IC