To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99666262_Sr__Quality_Engineer.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 08-Nov-2011
Sr. Quality Engineer
Lead investigations related to product and process deviations. Daily
activities may include auditing, document review, investigations,
writing of reports and quality system development and implementation
in both an individual and team setting. Review electrical, mechanical
and software/computer specifications in manufacturer and blue print
form. Assure protocols challenge the critical parameters related to
installation, operation, and performance of the related facility,
utilities, computer systems or equipment, and that protocols are
approved through proper channels. Ensure qualification protocols
comply per related SOPs and assure that acceptance criterion related
to validation and qualification protocols are met. Interact with all
involved personnel in the execution of protocols and gathering of test
data. Assure that all test data is gathered and recorded in accordance
with cGMP requirements. Ensure the analysis of data meets related
protocol acceptance criteria. Deviations are reported as required upon
failure to meet protocol acceptance criteria. Review Global and Site
validation related SOPs to assure they comply with regulations and
site requirements.
Education: Bachelor's Degree in Science, Engineering or related field
from an accredited college or university, and nine (9) – thirteen (13)
years related experience preferably in quality assurance or
engineering validation experience; or, an equivalent combination of
education and/or experience in a pharmaceutical environment.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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