US-GA-Atlanta: Quality and Validation Specialist
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99681190_Quality_and_Validation_Specialist.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 18-Sep-2008



Quality & Validation Specialist

Bachelors degree from an accredited college in a related discipline,
or equivalent experience/combined education, with 10 years of
professional experience; or 8 years of professional experience with a
related Masters degree. Considered an emerging authority. Required
skills: experience and equipment validation experience to include
software and computer systems.

Assures all program activities are performed in compliance with FDA
validation requirements and approved validation protocols, standard
operating procedures , and validation policies. Reviews and approves
all controlled documents to include Deviation Reports, Change Control,
and Validations/Qualifications; Reviews qualification studies as they
pertain to Installation, Operational and Performance Qualifications
for various types and sizes of cold storage units , transport
equipment, computer hardware and monitoring system software.

Review validation protocols and executed summary reports for
compliance. Conducts risk assessments and determines revalidation or
qualification needs. Coordinate all validation activities with
contractors and internal departments and review. Provide guidance and
training to program personnel and contract partners in the execution
and review of validation related activities;



Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com

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