*Job ID:AK_QRSD_NJ_051409 * ** Hi, My name is Harshal. I am an Executive- Intellectual Capital Development with Caresoft Inc.Our Team has been assisting the Client - on one of their critical Project.
I would like to check your availability and Interest for this opportunity. *Direct Client Requirements: * ** *Requirement 1: Quality Reviewer/SDLC* *Location: Summit,NJ* *Duration: 6 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. Focused on IT processes and in particular the *System Development Lifecycle (SDLC).* As such, this resource will be involved in the update and maintenance of this standard including the active monitoring of key project deliverables to ensure adoption across GIT. *Requirement 2: Quality Reviewer/Change Management * * Location: Summit,NJ Duration: 6 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. focused on *Change Management* and will be responsible for working with Change Board representatives across GIT to ensure comprehensive Release Management plans are developed and maintained. *Please reply with Following Details:* Availability for new project: Current Location: Willing to relocate: Best time to call & Contact No.: Expected Rate: Work Status ( Citizen /TN/ Green Card/ EAD/ H1B, Employer Details ) : Thanks & Regards, Harshal Vaishnao, Executive - Intellectual Capital Development Caresoft Inc. 40 Brunswick Ave. Suite 205 , Edison NJ 08817 URL : http://www.caresoftinc.com/ Phone -732-514-7761 Fax : 732-875-0595 eMail:*Harshal.vaishnao* @caresoftinc.com *** Among fastest 50 growing NJ Tech Companies 4 consecutive years - 2003,2004,2005 & 2006 - Deloitte & Touche *** Nominated for 2004 Fortune List of - 100 Best SM Companies to work for - Great Places to Work Institute / Fortune *** Microsoft Certified Partner, IBM Business Partner, SUN iForce Partner *** Featured among Top 100 Outsourcing Vendors in "Black Book of Outsourcing" By Outsourcing Management Institute ******************************************************************************************************************************************************************************************************* Note: Under Bill s.1618 Title III passed by the 105th U.S. Congress this mail cannot be considered Spam as long as we include contact information and a remove link for removal from our mailing list. 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