To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99684864_C
omputer_Validation_Engineer.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 19-Dec-2007
Computer Validation Engineer III / IV
Job Description Validation Engineers perform and provide
expertise in
the development, coordination and execution of computer
systems
validations in accordance with the GxPs, regulatory
requirements and
company procedures. Essential Job Functions: · Preparation
of
documentation for each computer validation study in a timely
manner,
which on approval will ensure a robust system consistently
meeting all
acceptance criteria · Coordinate and monitor computer
validation
studies as specified in Validation protocols and Validation
Plans ·
Execute computer validation studies in accordance with the
cGxPs,
regulatory requirements, validation master plans, procedures
and
protocols · Evaluate proposed changes to validated computer
systems
and execute validation where required. · Assimilate the
global
validation strategy and provide guidance to support several
local
sites in their effort to implement and validate Computerized
Systems.
· Solid knowledge of the cGxPs and some background in
either
manufacturing or quality control as well as project
management
experience · Candidates will facilitate communication
between the
Computer Validation Manager and local site Computer
Validation
Coordinators in form of direction and feedback Additional
Job
Functions: · Integration in a team of global Validation
Coordinators.
· · Direct involvement in the creation of specifications,
qualifications test protocols, traceability matrices and
reports. ·
Assistance in the achievement of audit readiness for each
facility
within the scope of the program. · · Coaching of the local
site
implementation teams in risk based validation. · · Strong
experience
with the Validation Lifecycle for Computerized Systems
including
creation of specifications as well as qualification
protocols and
traceability matrices. · Development of validation
strategies and
Validation Master Plans a plus. · Strong familiarity with
the cGxPs as
well as 21 CFR 11 and GAMP-4 required. · Familiarity with
the concept
of risk based validation, and project management skills
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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