Dear Partner, Here is an urgent requirement from caresoft. Most of our qualified submissions lead to immediate client interview. Therefore, please do not submit Candidates who are close to confirmation / placement. Please respond with Consultant's:- *Resume:* *Availability:* *Rate:* *Present Location:* *Contact number No. with Email ID:* ** *Location: Spring Field, NJ*
*Duration 10-12 months* Rate :Open *Atleast 2 PHARMACEUTICAL project EXPERIENCE A MUST* *QUALITY REVIEWER: * 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.* *Thanks & Regards, Ankur Nigam, Caresoft Inc. 40 Brunswick Ave. Suite 205 , Edison NJ 08817 URL : http://www.caresoftinc.com/ Phone 732-993-5362 Email : [EMAIL PROTECTED] gmail : [EMAIL PROTECTED] yahoo : ankurnigam2009* --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "SAP ABAP" 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.com/group/SAP-ABAP -~----------~----~----~----~------~----~------~--~---
