*Please send resumes if you have any matching profiles to
[email protected]*

* *

*Validation QA*

*Bridge Water, NJ*

*6-12 Months*



*Locals or near by . In person interviews. **– Should be SOLID GUY***



*Job Description:***



This position will be responsible for supporting testing and validation
activities for Global Infrastructure Solutions and computer systems.
Primary responsibilities include validation support for GIS. As required,
may also be responsible for validation support for other systems and
projects.

* *

*Education & Experience Requirements:*

   - Bachelor’s degree in Computer Science or related degree. 5 or more
   years’ experience in the *Life Sciences (Pharmaceutical, Medical
   Devices) and Healthcare industries*
   - 5 or more years’ experience in computer systems validation / QA within
   an FDA regulated environment *with good understanding of *
   - *cGxP (cGMP, cGDP, cGAMP, cGLP)* standards required. Thorough
   knowledge of *GxP and ERES (21 CFR Part 11 and Annex 11) regulations and
   guidelines*. Experience with risk management practices and tools.

This position requires excellent organizational and communication skills,
and a *thorough knowledge and understanding of FDA and international
regulations (EMEA, ANVISA).*

   - Experience in Software Development Lifecycle (SDLC) and working with
   GAMP 5 and ITIL.
   - Experience in QA Methodologies and software quality assurance.
   Experience designing, reviewing and approving Test Plans, systems and UAT
   test scripts and Test procedures. Experience with developing and following
   Change Control processes. Experience in creation / review of SOPs.

* Thanks & Regards*

*
*

*Ashok Kumar* | *United Software Group Inc.*| *Technical Recruiter
*Direct: 614-588-8520 • Fax: 866-764-1148 •
565 Metro Place South, Suite 117 • Dublin, OH • 43017

[email protected] • www.usgrpinc.com

*YIM:* ashokkumar_usg, *gtalk*: ashokumar.staffing

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