Hi,


Please find the requirement below and answer ASAP with updated resume and
contact details... Thanks a lot...

------------------------------------------------------------

Resumes with the following information will be given preference.



Full Name:

Current Location:

Relocation:

Availability:

Work Authorization in US:

Contact Number:

Email:

Rate on C2C:



Please ensure all candidates have all skills listed under "Required Skills"
on their resume.

----------------------------------------------------------------**

Vernon Hills  IL  USA  60061

Respond by Date 08/30/2010



Description

The DirectAccess ERP Integration Validation Lead will drive the validation
aspects of Baxter's validation of modifications/enhancements to the
DIrectAccess System to integrate with ERP.



Purpose of the Position:



1. Act as Validation Lead for DirectAccess ERP Integration project.

Critical Job Responsibilities:



1. Generate Validation Master Plan, Infrastructure Master Plan,
Qualification Protocols, Test Plans, Risk Assessments, Reports, Trace
Matrix, as needed.

2. Participate in and guide team in generating User Requirements, Functional
and Design Specifications. Provide guidance in generation of system
specifications.

3. Gain understanding and follow defined SDLC. Ensure quality validation
processes are executed as defined by procedures.

4. Using risk-based approach to validation, determine testing, documentation
and verification activities, with appropriate justification of the approach.


5. With team, develop validation strategy for the integration of
DirectAccess to the ERP system. Deploy strategy, defining documentation
requirements and hierarchy for system workflow validation.

6. Manage electronic routing of required documentation—ensuring compliance
to current procedure for e-approval.

7. Communicate status, solutions and concerns. Disseminate information in a
timely manner within the team. Facilitate and address issues within project.


8. Manage validation team—coordinating documentation and testing. Generate
test scripts, as needed. Execute testing as required.

9. Collaborate with business, quality, and technical individuals throughout
project in generation of project / validation required deliverables.

10. Prepare validation package for archival.



Required Qualifications:



1. Minimum BA / BS or relevant work experience in information systems,
engineering, science or business.

2. Highly skilled in Computerized System testing and validation in the
healthcare industry. At least 7-10 years validation experience in
application validation. Experience with both custom application and
JDEdwards a plus.

3. Proven results in managing validation aspect of software project
implementation.

4. Knowledge of International GxP regulations (e.g. 21 CFR Part 11, 211,
820, PIC/s), as well as Sarbanes-Oxley, HIPAA, and privacy regulations.

5. Experience with use/control of Electronic Records/Electronic Signatures
and electronic submissions to regulatory agencies.

6. Strong technical background from an application perspective--custom code
and JDEdwards ERP system.

7. Experience working in a highly regulated environment; GxP, QSR framework
preferred.

8. Solid project organizational skills. Ability to multi-task. Must have
strong analytical problem solving skills.

9. Excellent communication including written, verbal, and listening skills.

10. Self-motivated, detail oriented, takes initiative and ability to work
independently without close supervision.



Required:

Validation Lead =        5+ Yrs.



Comments
Individual chosen will be working with teams in Vernon Hills and McGaw Park,
Illinois

*Warm Regards !*

*Devender K*



*Technical Recruiter*

*Osair Technologies*

*301 N Harrison Street Suite#386**
Princeton,NJ 08540-3512*

*Contact: 630-566-7324| Fax :732-289-6076**
**...@osairtech.com, | **www.osairtech.com**.***



*"**We want to be your Trusted, Preferred & longterm Partner"*

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