Hi,

Hope you are doing great! Please find the requirement below , If you find
yourself comfortable with the requirement please reply back with your
updated resume and I will get back to you or I would really appreciate if
you can give me a call back at my contact number



*214-541-9047 Position: Validation Analyst With FDA Exp. Location: Santa
Monica, CA Duration: 6+ months*


* Sr. Business Analyst *

(With FDA Computer System Validation Experience)

This is a role calls for very specific expertise.  Need someone who has
worked on validations for the Food and Drug Administration (a Federal
Agency) and understands logistics (3PL = 3rd party logistics).



*Primary Responsibilities:*

*•Lead/manage Computer System Validation activities for a critical
enterprise project to establish a new distribution center with a 3PL*

•Key liaison between business stakeholders and technical teams, collaborate
with vendors to create Validation documentation, and review vendor
deliverables

•Create and manage Project Plan for Computer System Validation workstream
to support overall project go-live timeline

•And other responsibilities of a regular Sr. Business Analyst:

O Gather/analyze/document new or changes to business requirements, and
translate them into technical requirements

O Understands business problems and opportunities, and document business
process flows

O Facilitate discussion on business processes and systems and drive towards
agreement among multiple stakeholders

O Work with IT team to recommend solutions that meet business objectives

O Collaborate with vendor and manage vendor deliverables as needed

O Facilitate / develop test plan and test cases

O Assist in go-live activities and change management



*Qualifications:*

*•In depth knowledge of Computer Systems Validation experience in an FDA
regulated environment*

*•Hands on leader on managing and delivering deliverables for computer
systems validation projects*

*•In depth understanding of GAMP requirements and methodology for
implementation and control of FDA regulated computerized systems*

•Excellent documentation and communication skills

•*Knowledge of CGMP, 21 CFR Part 11 and Good Documentation Practices*

•Functional knowledge in Supply Chain Management

•6+ years of experience as a Business Analyst on large, cross-functional
projects dealing with multiple, complex process areas

*•Experience in multi-system integration; Knowledge with ERP systems and
WMS a big plus*

•Experience in process flow diagrams, use cases, current/future state
diagrams, functional and technical requirements

•Experience in collaborating with multiple vendors

•Good understanding of database schema and file structure

•Must be a self-starter and deliver results with minimal supervision

•Must be a team-player

•Project Management experience a plusb



* Please Share your details With your most updated resume.*



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Thanks And Regards,

*Pat Parker*
Technical Recruiter
*Ennovace Inc*
Ph: 214-541-9047
Fx: *972-913-8300*
[email protected]
Gtalk :- usapatp
www.ennovace.com
1801 S O'connor Rd
Irving TX 75061
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