Hello Partners,
Provide me your best consultant. Employer must be able to share visa copy along with DL copy. Please don’t share* OPT Visa holder resume.* *Please send your responses to vi...@gantecusa.com <vi...@gantecusa.com>* *Title: Computer System Validation (CSV) consultant * *Location: Edison, NJ* *Duration: 12 months* *Job Code: 15524* *Description*: The profile is of a Computer System Validation (CSV) consultant tool experience with 8+ years’ experience - 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 Regards, -- *Vinod Prem *| *Gantec Corporation* + 1111 Plaza Drive, Suite 470| Schaumburg, IL 60173| www.gantecusa.com : *vi...@gantecusa.com* <vi...@gantecusa.com> -- You received this message because you are subscribed to the Google Groups "SAP BASIS" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-basis+unsubscr...@googlegroups.com. To post to this group, send email to sap-basis@googlegroups.com. Visit this group at https://groups.google.com/group/sap-basis. For more options, visit https://groups.google.com/d/optout.
