Hello Associates, Please go through the below job description,and please let me know your interest.
*TITLE: CSV Consultant (Computer System Validation)* *LOCATION: Edison,NJ* *DURATION: 6+ Month* *Requistion Details:* *Duties:* - 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 validation - 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 audits - 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* -- You received this message because you are subscribed to the Google Groups "REQSRESUMES" group. To unsubscribe from this group and stop receiving emails from it, send an email to reqsresumes+unsubscr...@googlegroups.com. To post to this group, send email to firstname.lastname@example.org. Visit this group at https://groups.google.com/group/reqsresumes. For more options, visit https://groups.google.com/d/optout.