Facilities Deviation Writer
Core
Investigate and resolve facility deviations in a GMP environment to ensure product quality and compliance.
Role type
Senior IC quality engineer (deviations & investigations)
Builds
Compliant manufacturing operations and robust quality documentation
Domain
Biologics manufacturing / Pharmaceutical quality
Required skills
Deviation management, Root cause analysis, CAPA management, GMP compliance, Technical writing, Experimental design
Preferred skills
Data analytics, Digital skills, HSE knowledge
Responsibilities
Open and assess deviations within required timelines, Evaluate product impact of deviations, Author and drive investigations to closure, Apply structured root cause analysis methods, Design and execute experiments to support investigation outcomes, Develop and implement corrective and preventive actions
Seniority
Mid-level, hands-on IC