Please send me resumes to my official id "*swet...@lastwordconsulting.com
<swet...@lastwordconsulting.com>*"

Hi,

Please send me your updated resume if interested.

*Title*                       SAP FDA QA Lead

*Location*               Scottsdale , AZ

*Type*                     6 month

*Client: *                 CVS

*Functional Skills:*

At least 3 years of experience with software systems validation and
testing.

Requires thorough understanding of System Development Life Cycles for FDA
regulated applications.

Excellent understanding of test execution and typical defect management
practices in an FDA-regulated environment. Experienced with high volume
application testing environment.

Requires thorough knowledge of *US CFR 21 Part 11* regulations.

Requires working knowledge of at least one of the following: *US CFR 200 or
300 or 800 series*.

Experience of *HP Quality Center's Test Plan*, *Test Lab and Defect modules*
is required.

Knowledge of *SAP ERP for FIN, OTC, RTP, FTS* and* Logistics* processes is
a plus.

Experience with *automated Software Testing tools* is a plus.

Familiarity with *QA Systems* is a plus.

*Roles and responsibility:*

Act as a liaison between the compliance team, project team, and key
stakeholders for major SAP project.

Create and perform review and approval of documentation deliverables.

Enforce validation and quality requirements and Good Documentation
Practices for validation documentation.

Manage the routing and approval of system documentation through document
management system.

Must be comfortable in a leadership role.

Must be flexible to meet aggressive deadlines.

Partner with project team to communicate and understand compliance
requirements.

Report to the Compliance and Validation Lead, and provide status updates.

*Desirable Technical:*

Experienced in working within an FDA regulated environment for the
Pharmaceutical and/or Medical Device industries.

Ability to work within a Project Team setting.

Ability to guide a project team through the validation process.

Track, schedule and manage validation issues to ensure commitment dates are
met.

Jointly develop, communicates plan with project team.

Insure timely flow of information with project team.

Please fill the information matrix for the above position and send me your
updated resume.



Full Name:



Contact:



Email:



Current location (Complete address with zip code):



Open to relocate or Location preferences:



Currently in project:



Availability to start :



Visa Status with Validity:



Total Years of IT Experience:



Experience working in US:



Education (Passing year of Bachelors/Masters / University):



Date of Birth:



Skype id:



Expected compensation:





*Thanks and Regards,*

*Swetank Rana || Resource Manager*



*Last Word Consulting Inc.*
* Ph: **201 957 1000 Ext. 411* <201%20957%201000%20Ext.%20411>

*Email: **swet...@lastwordconsulting.com* <swet...@lastwordconsulting.com>

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