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Newsgroups: comp.databases.oracle.tools
Date: Thu, 12 Apr 2018 10:13:46 -0700 (PDT)
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Subject: IT Quality Analyst (Onsite) - Sunnyvale, CA
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Xref: news.netfront.net comp.databases.oracle.tools:2219

Hi,
Hope you doing well,
we do have opening with one of our Client please go through the below Job D=
escription and share profiles to vijay@santeksystem.com / 510-256-5798
(please don't share profile if you not able to provide passport num )

Job Title
=09

Consultant - IT Quality Analyst (Onsite)

Reporting To
=09

Onsite =E2=80=93 IT Compliance Lead

Location
=09

Sunnyvale, CA =20

=09

Position Summary
=09

Perform quality and compliance checks of activities during the project/oper=
ational phase of the computerized system. Train the support teams on define=
d SOPs, track open issues and risks and ensure they are addressed by respec=
tive teams.

Key Result Areas
=09

-         Play the role of change coordinator

-         Prepare and facilitate IT Change Review Board meetings

-         Initiate / monitor and track to closure of changes and CAPAs thro=
ugh tools like SolTraq, SNow, etc

-         Understand SOPs, client System Life Cycle

-         Understand existing processes in application area

-         Review and coordinate the draft protocols/test cases

-         Review validation deliverables

-         Support periodic reviews

-         Manage and monitor Audit and CAPA management

-         Align and report to IT Compliance Lead

-         Co-ordinate with offshore team to share the tasks and meet delive=
rable timelines

Qualification
=09

-         Minimum requirement is a Bachelor=E2=80=99s Degree in Computer Sc=
ience, Sciences or a related education (e.g. life science, medicine, commer=
cial).

-         Minimum 4 years Professional experience in managing quality / com=
pliance in the regulated environments in a Pharmaceutical/Life Sciences Org=
anization.

-         Expert knowledge of GAMP5, Quality Management, Computer Systems V=
alidation (CSV) and change management in a GxP environment.

=20
