Assurance (QA) representative providing QA oversight and support to ensure compliance to GMP. Drive quality on the... and regulatory compliance with 21 CFR Parts 210/211, 820, ISO 13485, USP and ICH guidelines. Support product validation (IQ/OQ/PQ...
on active instrumentation and equipment to include IQ (Installation Qualification), OQ (Operational Qualification) and PQ..., maintenance, repair, and performance verification documents. Prepare documentation for Quality Assurance approval prior to work...
effectively within DPT and across Amgen functions, including Drug Substance Technologies, Attribute Sciences, Quality Assurance... and effectively with external industry groups, such as the IQ Consortium, and academic partners, such as university consortia...
with Quality Assurance and Engineering. Supplier Performance & Risk Management Monitors supplier performance, identifies risks... and mitigation plans in collaboration with Quality Assurance and Materials teams. Collaborates with suppliers and internal...
with Quality Assurance and Engineering. Supplier Performance & Risk Management Monitors supplier performance, identifies risks... and mitigation plans in collaboration with Quality Assurance and Materials teams. Collaborates with suppliers and internal...
provides Operations, Quality Assurance, clients, and regulatory bodies with scientifically sound, documented evidence... equipment and validation procedures for Installation Qualification (IQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities...
, and ensuring effective operational management. Leads critical quality engineering and assurance tasks, ensuring the maintenance...’ experience in FDA regulated medical device manufacturing environments, with a focus on Operations/Process Quality (IQ/OQ/PQ...
closely with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering, this individual..., palletizers, and packaging equipment Equipment startup, commissioning, and qualification (FAT, SAT, IQ, OQ, PQ) Packaging...
with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) Assess Supplier...) 0-2 years’ experience in quality assurance;experience in the medical device industry preferred GMP and ISO experience...
closely with Manufacturing, Quality Assurance, Validation, Automation, Maintenance, and Project Engineering, this individual... filling operations Equipment startup, commissioning, and qualification (FAT, SAT, IQ, OQ, PQ) Process optimization...