QA Manager
Knowledge: Thorough understanding of cGMP, FDA, EMA, and other regulatory requirements. Leadership Skills: Strong leadership...
Knowledge: Thorough understanding of cGMP, FDA, EMA, and other regulatory requirements. Leadership Skills: Strong leadership...
, Illinois, 62704-4462 Agency Contact: EMA[email protected] Posting Group: Legal, Audit & Compliance Revolving Door...
regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc). Knowledge and practical experience in...
on product clearances thru FDA, CVM, EMA and AVPMA regulatory submissions, approvals and ongoing maintenance programs...
within a pharmaceutical or CRO setting. Strong knowledge of regulatory guidelines (GLP/ICH, FDA, EMA, etc.) governing bioanalytical testing...
inspections (FDA, EMA, etc). Responsibilities · Coordinate the end-to-end inspection readiness activities, including...
guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Arcus Standard...
function in a cGMP manufacturing operation. Experience in FDA/EMA or similar regulation in biotechnology or cellular therapy...
of competence. Stay current with laboratory regulations from such entities as USP, FDA, EMA, WHO. What You Need to Succeed...
with community utility service providers,police/fire/sheriff/EMS, and EMA departments in Columbus as well as nearbyjurisdictions...