SQAFYI - Software QA Resource - FYI

US: QA-Compliance Professional

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

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI

US: QA-Compliance Professional