Hello Associates,
Please go through the below job description,and please let me know your

*TITLE: CSV Consultant (Computer System Validation)*
*DURATION: 6+ Month*

*Requistion Details:*


   - Total IT experience 9+ Years
   - Knowledge of  industry standards & regulations
   - Ability to work independently & handle the entire project

*Position Skills Requirements:*

   - 8+ years of experience in CSV Implementation
   - Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11
   on electronic records, electronic signatures etc.
   - Define Risk based strategies for validation of computerized systems
   and author/review end-to-end Computerized Systems Validation documentation
   in accordance with Computerized Systems Validation Master Plan
   - Perform system risk assessments, systems gap analysis, review and
   approve action plans to ensure compliance during and after the system
   - Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV
   - Help, guide and direct the project manager during the system
   implementation and validation process, and ensure compliance with corporate
   policies and procedures.
   - Provide training related to computerized systems validation, quality
   and compliance to users and appropriate personnel
   - Experience in Internal Audit, External Audit. Face regulatory,
   customer, IT Quality System related inspections for all computerized systems
   - Responsible for review & verification of Corrective Action Plan for
   - Perform periodic review/monitoring of computer systems implemented
   - Proven experience in developing Master Validation Plan, validation
   scripts, Validation reports, all documentations required during CSV
   Implementation Process

*Methodology/Certification requirements:*

   - Bachelor Degree in Engineering, Computer Science OR equivalent through
   experience. Advanced course work in technical systems plus continued
   education in technical disciplines is preferred
   - Language proficiencies
   - English spoken and written


*Rajat Kumar*
*ll IT-SCIENT ll Phone: 510-516-7859 ll Official: rajat.
<surajkumar.itsci...@gmail.com>s...@itscient.com <s...@itscient.com>*
*ll Email: rajat.itsci...@gmail.com
<surajkumar.itsci...@gmail.com> ll Web: www.itscient.com
<http://www.itscient.com/> ll*

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