Hello All,
Please find the Job Description and let me know the interest. Please reply
at singhpiyush.itsci...@gmail.com* or  *piyus...@itscient.com



Position: Validation Engineer

Location: Rocky Mount, NC

Duration: 6+ Months



*Job Description:*


   - Experience in Empower, NuGenesis, Chromeleon, or WinKQCL is desired.
   - Environmental Monitoring or program design experience desired
   - Working knowledge or biology, chemistry, life sciences with strong
   skills in computer system management.
   - Knowledge of cGMPs and regulatory requirements around computer systems
   including 21 CFR Part 11, GAMP5, and applicable ISO standards.
   - Strong analytical skills and balanced decision making; must have the
   ability to formulate appropriate system queries.
   - Provides technical support for laboratory quality system to the
   quality control laboratories, Biological Quality (BQ), Chemical Quality
   (CQ), and Supplier Quality (SQ)
   - Ensure that the systems comply with all relevant regulatory standards
   including assessing systems for CFR Part 11 compliance/ISO Part 11
   compliance.
   - Diagnotic support for application.  Management and timely resolution
   of technical incidents through the standard incident and problem management
   process
   - Responsible for elevation of incidents to 2nd tier support and
   summarization and reporting of incidents to system owners and effected
   users when required.
   - Ensure site on-time implementation of laboratory quality system
   through support of requirements definition, functional design, management
   of master data configuration, data migration, reporting design, system
   validation, SOP generation, development, and end-user training.


Desired years of experience:  8+


-- 



*Thanks & Regards  ......Piyush  || Technical Recruiter |||| IT-SCIENT ||
Fremont, CA ||  *
* Fax: 877.701.4872 || Emai: singhpiyush.itscient@
<singhpiyush.itsci...@gmail.com>gmail.com
<singhpiyush.itsci...@gmail.com> or piyus...@itscient.com
<piyus...@itscient.com> || Web: www.itscient.com
<http://www.itscient.com/> ||*

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