At least 5 years' experience in a regulated/GMP industry required
This position requires a candidate with regulatory inspection experience to lead Nitto Avecia's inspection readiness program.
Comprehensive working knowledge of cGMP's/FDA regulations, Quality systems, FDA Guidance documents, USP, ICH and other applicable laws and their interpretation, implementation
Proficient with PC-based word processors and spreadsheets.
Proficient with electronic quality management systems
Intermediate understanding of ICH, ISO, cGMP, USP, EU, and other relevant regulatory guidance/requirements.
Experienced in the use of electronic systems such as eQMS
Requires the ability to gown into clean rooms and wear PPE.