in IQ/OQ/PQ validation activities including the drafting, review, and execution of protocols. Apply statistical tools... proper documentation and actions related to risk assessment are complete. Train Quality Assurance Inspectors...
Seeking a Specialist, Quality Systems to provide Quality Assurance support for early-stage gene therapy candidates.... This position is part of the Quality Assurance group and will be responsible for supporting the companys quality management systems...
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...
quality standards through consistent application of Quality Assurance principles, training, communication, and regulatory... daily operations. Required Qualifications: B.S. or B.A. Degree in Science-related field, Quality Assurance, Engineering...
URS, FRS, IQ/OQ/PQ protocols, validation reports, periodic reviews, and revalidation activities. Ensure compliance...-on experience executing the full validation lifecycle, including system validation, Computer Software Assurance (CSA), data...
activities. Participate in IQ/OQ/PQ validation activities, including drafting, reviewing, and executing protocols... product and process changes to ensure documentation and risk assessment actions are complete. Train Quality Assurance...
-functionally with Manufacturing, Process Sciences, Supply Chain, Quality Assurance and external vendors to ensure compliant.... This includes equipment specification, procurement, installation / start-up, testing, onboarding, and qualification (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...
, you will collaborate across functions to provide quality assurance support for all aspects of New Product Introductions, focusing on long... Installation Qualification (IQ), Measurement System Analysis (MSA), Operational Qualification (OQ), and Performance Qualification...
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...