US-GA-Atlanta: Quality and Validation Specialist

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;

For more information, please write to us.

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