*Hello *


*Hope you are having a wonderful day. *

*My name is Anurag Upreti and I am a part of recruitment team at Sysmind
LLC.  I came across your profile and wanted to see if you would be
interested in Position as Software Quality Assurance manager with one of
our customer located in Waukegan, IL, US*

*Please let me know your thoughts on this exciting opportunity with us.*



*Feel free to reach me out at  anu...@sysmind.com <anu...@sysmind.com> or
call me at 609-897-9670 Ext 4002*

*Job Title: Quality Assurance manager*

*Location: Waukegan, IL, US*





*JOB DESCRIPTION**:  *












*Primary Job Function Primarily responsible for basic level quality
assignments, for example, reviewing/auditing, and authoring project
documentation associated with the SDLC to support Corporate, Division, FDA,
and other regulatory requirements.  This role assists with activity
supporting the QA System and business driven objectives.  In addition to
these primary areas of focus, quality assurance will assist with project
work related to: -Infrastructure (Hardware or Layered Software
Installations) -Application quality -Compliance initiatives -Validations
-Internal / supplier audits -CAPA system investigation, confirmation, or
verification.*



*Responsibilities:*

































* Job Responsibilities 1. Accountable for supporting project documentation
for the software development lifecycle (SDLC for quality and non-quality
applications. 2. Supports projects by: a. Reviewing test data and
supporting validation documentation b. Assisting with system design to help
design in quality to systems c. determining validation strategies based on
system design. d. Creating protocols to challenge system functionality e.
Coordinate final package submission to QA library or other library projects
as necessary f. Providing administration for validation review board
meetings. 3. Responsible for recognizing and elevating sensitive quality
and regulatory issues for applications, layered software, & hardware. 4.
Recognize gaps in project documentation and recommend modification to the
quality and non-quality systems. 5. Assist in developing and maintaining
written policies, processes, and procedures related to the quality system.
6 Assist in providing training and/ or training material related to the QA
Program. Accountability Responsible for ensuring that Corporate and
Divisional systems (applications, layered software, & hardware) are
compliant to AbbVie internal, FDA, and other regulatory requirements.  The
absence of consistent implementation and enforcement of compliance could
lead to regulatory action. Financial penalties to the corporation or
division(s) are possible consequences. Education Bachelors Degree, Science,
IT, Business or Engineering Experience and Training Experience in a formal
software development life cycle (minimum 5 years).  Experience in regulated
software environment. (minimum 3 years)  Software Quality experience
(Minimum 3 years), ).  Must be familiar with applicable US regulations (GMP
parts 11, 58, 210, 211, and 820).    Experiences that are considered a
plus: -Former Abbott or AbbVie experience -Project Management -Auditing
Experience -Quality Systems experience*



*Total experience required : 8+yrs*



*Kindly Reply me back with all these details and your updated resume, if
you are comfortable with this requirement.*



*Full Name *



*Contact Number *



*Email Id *



*Current Location *



*Open to Relocation *



*Visa Status (visa expiration date) *



*Availability to start  (End date of project)*



*Available for interview (timing)*



*Highest Qualification with Year   *



*Date Of Birth (DOB)(Day/ Month/ Year)*



*Overall IT Exp *



*Overall US work Exp        *



*Relevant Experience as per requirement*



*Skype Id*



*Employer detail*



*Current project status(finish/working)*



*Reference – 1(present project )*



* Name *

*Ph no.*

*Official mail id *

*Designation:*





*Reference – 2(Past  project )*



* Name *

*Ph no.*

*Official mail id *

*Designation:*



*            Education*

*Passing Year*

*University *

*Bachelors in: with%*





*Masters in: with%*









*Thanks & Regards*



*Anurag Upreti*

*IT Recruiter*

*Website:www.sysmind.com <http://www.sysmind.com>*

*Email: anu...@sysmind.com <anu...@sysmind.com>*

*Phone:609-897-9670 Extn 4002*

*Fax: 609-228-5522*

*Address: 38 Washington Road, Princeton Junction, NJ 08850*

*[image: Description: Description: Description:
cid:image001.gif@01CC0A79.D4FFDB80]*

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