صاحب العمل نشط
0 - 11 سنوات
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أي جنسية
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1 وظيفة شاغرة
The QAOperations Specialist is responsible for quality assuranceoversight of manufacturing, testing and supply chain operationswith current GMP regulations, procedures and qualitysystems. JobDuties Provide shopfloor quality oversight ofall production, quality control and supply chain departments toensure their practice fully adheres to cGMP, including dataintegrity. Ensure timely escalation to management of all applicableincidents. Perform live review of manufacturingbatch records in preparation for batch release and escalate anydiscrepanciesimmediately. Assist functional areas with achievingtimely and compliant final product disposition of theproduct. Review, approve and support proceduresand production / testing records as required and assist in thetraining of siteassociates. Ensure compliance of sitepersonnel and application of aseptic techniques and full complianceto sterile manufacturingregulations. Support FDA / Regulatory interactions forthe Indianapolis site activities and products to ensure successfulregulatory submissions andinspections. Support QA Operations as a valuedbusiness partner, with a culture of safety, quality, delivery topatients, cost, compliance and dataintegrity. Other relatedduties asassigned.
دوام كامل
التسويق / إدارة العلامة التجارية / بحوث السوق / التسويق الرقمي