US-PA-North Wales: Computer QA Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 04-Sep-2008

Computer QA Engineer

Bachelor's Degree in computer science or science-related field or similar degree with applicable experience.

* 10-15 years pharmaceutical and computer validation experience or equivalent combination of education and experience.

* Minimum 4 years supervisory experience or proven leadership capability.

* Working knowledge of FDA compliance, specifically in 21CFR Part 11 regulations and GAMP guidelines.

* Knowledge in IT standards, procedures, various platforms, configurations, project life cycles and change control systems/databases is mandatory.

* Skilled with computer software packages, such as: Microsoft Office, Lotus Notes, Mercury Interactive Tools, LIMS, TrackWise.

* Knowledge of ERP integrated software and Electronic Document Management systems.

* Effective utilization of WebEx.

* Working knowledge in harmonizing/standardizing complex systems which affect multiple departments.

* Lean or Six Sigma knowledge/experience a plus.

* Strong interpersonal and communication skills, especially those to serve as a liaison between various departments/teams.

* Ability to work independently

Individuals with equivalent combination of education, training, and related experience will be considered. Understanding of cGMP's, Part 11 Requirements, Team Training, Situational Leadership, Facilitation Skills, Coach/Mentor Certification a plus Experience with project management, good presentation skills, experience in Lean Manufacturing, leadership in a formal team environment, previous pharmaceutical experience

For more information, please write to us.

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