US: QA-Compliance Professional To apply for this position, please visit this Website. http://sqa.fyicenter.com/jobs/99674774_QA_Compliance_Professional.html To see other opportunities, please visit http://sqa.fyicenter.com Date: 22-Jan-2010
QA-Compliance Professional Requirements • 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 MDD’s; 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 Thank you, Team SQAFYI - Software QA Resource FYI http://sqa.fyicenter.com -- You received this message because you are subscribed to the Google Groups "Software Quality Assurance Center" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/software_qa_center?hl=en.
