Hi,
Hope you are doing well.
We have urgent requirement for '*Computer Systems Validation - Trackwise
Lead/Manager*'
Apply to shaik.imt...@avanceservices.com or call +1-732-276-9933 Ext: 408.
Title: *Computer Systems Validation - Trackwise Lead/Manager *
Location: *Foster City, CA*
Duration:* 6+ Months*
*Job description:
*
- 8+ years 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
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 shaik.imt...@avanceservices.com or call +1-732-276-9933 Ext: 408.
--
Best Regards,
Shaik Imtiaz
Talent Acquisition Member
+1 732 276 9933 *Ext :* 408
shaik.imt...@avanceservices.com
http://www.linkedin.com/in/imtiazskmd
[image: Avance Services] <http://www.avanceservices.com/>
www.avanceservices.com
Avance Consulting | 29 Walter Hammond Pl | Waldwick NJ 07463 |
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