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FDA resumes in Franklin Park, NJ

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Qa Lead Computer System

Edison, NJ
... Evaluates validation activities and documentation to ensure that they meet FDA standards, User Requirements, deliverables such as Validation Plan, Test Plan Protocols, Validation Summery report, Risk Assessments Reports, Experience in generating, ... - Feb 22

Computer System Validation

Edison, NJ
... Evaluates validation activities and documentation to ensure that they meet FDA standards, User Requirements, deliverables such as Validation Plan, Test Plan Protocols, Validation Summery report, Risk Assessments Reports, Experience in generating, ... - Feb 21

Human Resources Patient Care

Edison, NJ
... Clinical Quality Program Standards Drug Utilization Review Medication Therapy Management Medicare and Medicaid Processes FDA Drug Safety Guidelines and SOP for operations Soft Skills: Detail-oriented, time management, collaborative, teamwork, ... - Feb 19

Regulatory Affairs Project Management

Bridgewater, NJ
JEAN HALLORAN 908-***-**** (Cell) ad3q98@r.postjobfree.com PROFESSIONAL SUMMARY Experienced and dedicated Regulatory Professional with over sixteen years of Regulatory experience in the pharmaceutical industry with a strong focus on FDA Submissions. ... - Feb 19

Software Development Management Process

Edison, NJ
... Compliance – Ensured compliance with all CCT standards, SOX, FDA, GXP, CSV, 21 CFR part 11, SDLC, SOP and other regulatory requirements. Celgene Inc. – Summit, NJ (http://www.celgene.com) IT Consultant February 2005 – April 2006 IT Projects – ... - Feb 17

Database Administrator Sql Server

Princeton, NJ
... Created multiple Oracle instances for Argus Safety & Risk management application according FDA regulations. Setup and Configure HA solution using Oracle physical standby database. Recover standby database as and when required. Monitor and ... - Feb 14

Medical Reviewer Drug Safety

Edison, NJ
... Well versed with regulations related to prescribed products and medical devices and current with the regulatory requirements and expectations including EMA ICH GVP Modules, FDA IND and NDA reporting requirements and global risk management ... - Feb 09

CUSTOMS ENTRY WRITER

Roselle Park, NJ
... commodities and multiple lines -Upon filling Entry provide release details to LFD (3461 and ACE results) -Advise OGA status, FDA or Agriculture holds or releases -Upload supporting documentation via DIS or ITACS -File CF-7512/IT In-Bond and arrive ... - Feb 09

Quality Assurance Control/Production Management

Parlin, NJ
... * Reviewed and approved Batch documentations for FDA regulated products. * Document control coordinator for the organization, keeping track of procedures and their lifecycle, issue new procedures and archive old when no longer needed. * Setup ... - Feb 06

Supply Chain General Manager

Somerset, NJ
... P&L Management - *Technical:* Project Management, Hazmat Certified, 5S & LEAN, Microsoft Suite - *Regulatory:* DOT, FDA, OSHA, Safety & Security Control **Professional Experience:** **United Parcel Services (UPS) - Transportation Department* ... - Jan 23
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