Hello,
Job Title: *Validation Project Manager*
Location: Foster City, CA
Duration: 6 Months
*Job description / Key qualifying skills:*
Experience in Quality and Compliance with substantial hands-on computer
system validation experience
Prior experience leading/mentoring other validation professionals
Prior experience working with offshore teams
Experience in FDA regulated environment with good understanding of GxP
related processes including Risk Based 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 with in Change Control processes.
Experience with various FDA regulations (e.g. 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.
Perform assessments of computer systems and processes at client sites
(compliance with internal procedures, industry best practices, and
regulatory requirements)
Develop validation strategy documents, write user requirements, SOPs,
IQ/OQ/PQ, and create validation summary reports
*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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