US: QA-Compliance Professional
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please visit http://sqa.fyicenter.com
All forms of Validation document development and execution:
Process, Equipment, Software (CSV), Laboratory (Methods), Manufacturing, Cleaning, Facilities/Utilities, and Change Management.
Experience as a Quality Engineer or the related techniques Experience with Software Quality Assurance, particularly in the area of SAP validation, upgrades, and implementation support Experience with Quality Systems in the areas of auditing, training, implementation, and remediation.
Experience conducting non-conforming product investigations/out of specification reporting
Complaint Handling and MDRs/adverse event reporting. Familiarity with FDA regulations 21 CFR Part;: 11, 210, 211, 820, etc.
, and ISO Standards (13485); European MDDs; and the CMDR Experience creating Regulatory and Quality Training for all cGXP, FDA, ICH, GHTF Guidelines/Regulations, and ISO standards Warning Letter and FDA Inspection Remediation
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Team SQAFYI - Software QA Resource FYI