Hi,
Please send resume to an...@aim-cc.com *Business Analyst Change Management* *Location:** *Peapack NJ *Duration:*12 months Pharmaceutical experience is desired. Responsibilities include, but are not limited to, the following: * Process and track chemistry/manufacturing documents generated * Regular interaction with CMC (Chemistry, Manufacturing and Controls) product principals, regulatory affairs, global manufacturing sites and Manufacturing *center* function colleagues to expedite chemistry/manufacturing change implementation * Create reports for tracking documents * Data entry and storage of manufacturing control documents in an electronic document management system * Assign document code numbers for manufacturing control documents * Conduct administrative quality check of documents received from manufacturing sites * Draft business practices, checklists and general procedures for new processes * Create and manipulate reports from Global Regulatory System (GRS) and TrackWise * Submission of variations/supplements * Track submission and approval of changes * General clerical duties as needed * Scan documents into electronic format * Import documents into several document management systems following GMC business rules * Create virtual documents * Communicate regulatory status of change to manufacturing sites Qualifications: * College degree desirable * Applicant must be computer literate with demonstrated skills in Microsoft Office Applications (i.e. Outlook, Word, Acrobat, Excel, Access and Powerpoint); familiarity with Documentum software a plus * Excellent organizational, interpersonal and communication skills a must, international exposure a plus * Proofreading and document scanning abilities required * Detail oriented * Knowledge of Navigation tools, Documentum, Microsoft Access spreadsheets and databases a plus * Experience with NDAs, MAAs, Part IIs, CTDs, eCTDs would be useful * especially CMC section * Manufacturing experience and/or regulatory affairs experience a plus. *Have a blessed day!*** *Thanks & Regards* *Annie Mark **|*Aim Computer Consulting | 734-591-3562 EXT: 1+180|Fax : 734-418-2603 Mail id: an...@aim-cc.com Yahoo IM: annie_...@yahoo.in Visit our Website at www.aim-cc.com _________________________________ Please visit www.NRIYP.com <http://www.nriyp.com/> New generation Yellow pages for NRI’s Classifieds<http://www.nriyp.com/Classifieds/Classifieds_Home1.aspx?Country=> |Yellow Pages <http://www.nriyp.com/>|Travel<http://www.nriyp.com/Travel/TravelHome.aspx> |Classmates <http://www.nriyp.com/Classmates/Classmates_HomePage.aspx> --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "Microsoft DOTNET ASP, C++, SQL SERVER" group. ------------------------------------------------------------------------------------------------------------- ------------------------------------------------------------------------------------------------------------- For stunning photoshop tutorials, visit: www.psd-help.blogspot.com ------------------------------------------------------------------------------------------------------------- ------------------------------------------------------------------------------------------------------------- -~----------~----~----~----~------~----~------~--~---
