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*LOCALS OR NEED TO GO FOR THE FACE TO FACE ON OWN EXPENSES*** *Location: Kenilworth, NJ * *Rate: $40-42/hr all inclusive C2C* *Duration: 2 Months* Supports the design and maintenance of software, hardware and instrument development projects with responsibility for assuring quality in relation to 21 CFR Part 11 and other compliance requirements within the sponsoring departments. *MAJOR ACTIVITIES AND RESPONSIBILITIES:* *60 percent - Advisor to Project Teams* Participates as a subject matter expert on *21 CFR Part 11* and other compliance/quality related activities that are part of good system development Is responsible for authoring portions of the *quality documentation*creation as per the departmental level SOPs and practices Assures that project teams are fully versed on the requirements of systems in all lifecycle phases to be in a state of sustained compliance and imbeds those requirements into new system development projects as well as ongoing maintenance for legacy systems *20 percent - Internal QC Review* Has the responsibility to help develop and document compliance strategy solutions in the 21 *CFR Part 11 Compliance Strategy Document*. In some cases, will take ownership of assessment documents within the sponsoring department and will transition these assessments, with the help of business and technical subject matter experts, into workable Compliance Strategy Documents. In situations where the business owner will write the CSD, the Quality Control Manager will partner with that person and will sign the CSD indicating that they approve of the strategy for meeting the Assessment gaps. *20 percent- Controls Vendor Audits* Attends or sends appropriate delegation to all vendor audits (system or service vendors) for the sponsoring department to represent the *21 CFR Part 11* and other compliance related requirements for that *department based on its SOPs and/or practices* *Warm Regards** * *Vikas Aryan* *Ambrosia Infotech Ltd - 3086 "Synerging Minds"* *Route 27, Suite No: 9,* *Kendall Park, New Jersey 08824* *609.662.1279 *230|| F: 609 228 4646** [EMAIL PROTECTED] *www.ambrosiainfotech.com* <http://www.ambrosiainfotech.com/> *http://www.sarpit.com/KVikas.html* <http://www.sarpit.com/KVikas.html> *http://www.linkedin.com/in/vikasaryan*<http://www.linkedin.com/in/vikasaryan> --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "JAVA-J2EE-RMI" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [EMAIL PROTECTED] For more options, visit this group at http://groups.google.co.in/group/JAVA-J2EE-RMI?hl=en -~----------~----~----~----~------~----~------~--~---
