Hello,
Job Title: *Trackwise Admin*
Location: Foster City, CA
Duration: 6 Months
*Job description / Key qualifying skills:*
Trackwise configuration, implementation,URS/FRS writing.
Experience in 2-3 implementations.
Experience in FDA regulated environment with good understanding of cGxP
(cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.
Experience in Computer system validation.
Experience in reviewing system test and user acceptance test scripts,
Traceability matrix and Design Specs.
Experience in writing and executing documentation for all aspects of the
validation deliverables (etc. Requirements, Compliance/validation Plans,
test protocols, Test Summary reports and Compliance/validation reports.
Experience in Software Development Lifecycle (SDLC).
Experience in QA Methodologies, designing, reviewing and approving Test
Plans, systems and UAT test scripts and Test procedures.
Experience in Change Control.
Experience on various FDA standards (21 CFR Part 11, 210, 211, 820)
Experience is creation of SOPs.
Knowledge of FDA guidance's and industry standards (i.e., GAMP)
Hands on experience in HP Quality Center and QTP.
Strong verbal and written communication skills.
Able to work as a team player, lead a team or accomplish tasks without
supervision.
Ability to work with remote teams and support several changes/projects
simultaneously.
Flexibility to work with an onshore/offshore model.
Participate in the development of strategic compliance deliverables to
support applicable regulations and internal policies and to ensure systems
to be developed adhere to corporate SDLC methodology.
Drive understanding and adoption of Quality and Compliance standards.
Ensure Quality & Compliance requirements are considered in any initiative
or major change request.
Ensure the compliance deliverables are updated and kept current with all
applicable changes.
*Company :*
A Global IT consulting firm with several large customer engagements across
Europe and US. It provides strategic business consulting, technology,
engineering and outsourcing services to help clients leverage technology
and create impactful and measurable business value for every IT investment.
*About Us :*
Avance Consulting is one of the UK& US’s fastest growing talent acquisition
companies. Head quartered in London, we are a global reach agency with a
large presence in UK, Europe, US and India.
APPLY now with your updated resume in word format. All selected profiles
will be contacted within 1-2 days of application receipt.
Apply to syed.ab...@avanceservices.com or call +1-732-276-9933 Ext: 485.
--
Best Regards,
Syed Abdul
Sr. Talent Acquisition Member
+1 732 276 9933 *Ext :* 485
syed.ab...@avanceservices.com
www.linkedin.com/in/syedabdul/
[image: Avance Services] <http://www.avanceservices.com/>
www.avanceservices.com
Avance Technology Services Inc | 29 Walter Hammond Pl | Waldwick NJ 07463 |
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