Quality Specialist-Regulatory is responsible for assisting the Sr. Quality Manager ensure accreditation readiness... Quality Specialist-Regulatory will also to improve quality assurance, workflows, and processes within the Department...
Overview: Job Summary: Specialist role to provide Quality oversight in manufacturing operations at the site... and monitor processes for adherence to established procedures/regulatory compliance. As part of an inter-departmental team...
release checklist and COA’s Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well... as guidance documents (ie: ICH, ISPE, etc.). Interact with Manufacturing management to provide quality perspective on routine...