Hi,


Hope you are doing great!



I have an immediate requirement for *Computerized System Validation – CVS
Consultant *with one of my Client at *Skillman, NJ.*



Please let me know if you have any consultant for any of the below skill
set.



You can reach me at 847-440-2436 x 365.



*Computerized System Validation – CVS*

*Skillman, NJ*

*6+ Months Contract*



*Job Description:*

   - *Good exposure to computerized system validation framework:*


   - Compliance Plan, Compliance Analysis & Assessment
   - Risk assessment & Mitigation
   - Change Control and management
   - Incident management
   - Quality, Coverage and Regulatory Assessment
   - 21 CFR Part 11/Part 820, gap analysis


   - *Good Exposure to review of:*


   - User requirements, Functional/Design specification
   - Test scripts in HP ALM or other tools for user acceptance, system test
   and regression tests.
   - Change Requests/Change orders in solution manager or equivalent tools
   - Incidents and trending based on risk and priority


   - Good exposure to Defect and Deviation Management, Non-conformance and
   CAPA processes.
   - Design review and system acceptance.
   - *System Qualification:*


   - Validation strategy creation
   - Qualification protocol creation
   - Test Protocol creation (IQ/OQ/PQ)
   - Qualification protocol summary report generation
   - validation summary report generation
   - Trace Matrix generation


   - Good experience of different SDLC methodologies: Agile methodologies
   and risk based validation in particular.
   - Good exposure to ERP systems (SAP applications).
   - Good exposure to create work instructions & SOPs.
   - Client interfacing, front ending multiple business process groups
   individually and providing daily/weekly/monthly updates to clients.
   - Portuguese language is mandatory along with good English language.



Best regards,

Nihal Singh | Sr. Technical Recruiter



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*DeegitTM Inc* | Technology Consulting



1900 E Golf Rd., Suite 925 | Schaumburg, IL 60173



*Phone* 847-440-2436 ext:365



*Email* ni...@deegit.com



*Skype* nihalsinghaarakash

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www.deegit.com

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<https://in.linkedin.com/in/nihal-singh-32854133>

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