HI,

 

Duration of Project: 5 months

Projected Start Date: ASAP

Location: Warren,NJ

Number of Consultants Needed: 1

 

Please don't submit Resumes without Pharmaceutical/Biotech industry
experience

 

Summary: This position requires someone who has had experience in Quality
for Information Technology in the Pharmaceutical/Biotech industry (knowledge
of software development/testing processes in a regulated environment).
Their tasks will include

*       developing process maps of both Abraxis & Celgene IT processes

 

*       software development
*       testing
*       change management
*       defect management
*       problem/incident management
*       training
*       document/data management
*       business continuity/disaster recovery
*       infrastructure operations
*       end-user support
*       etc.

*       gathering compliance and audit documents for review
*       inventorying Abraxis IT related Quality documents (such as SOPs and
Work Practices)
*       evaluating Abraxis documents/processes against the Celgene
documents/processes

*       identifying gaps
*       identifying differences in equivalent documents/processes

 

Skills/Knowledge Required:

At least 5 years experience in the pharmaceutical industry in Information
Technology in a regulated area.  Must be familiar with GxP regulations and
Good Documentation practices.  Experience in writing/evaluating procedural
documents.  Experience in evaluating compliance and audit documentation.
Experience in developing process maps.  Experience with standard IT
processes such as are listed above.

 

 

 

Thanks and have nice day!

____________________________

Deepak

American IT Associates Inc 

E-Mail:[email protected]

Yahoo & Gtalk : deepu.handy
www.aita-inc.com

 

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