Job Details

  • Title: Compliance Administrator
  • Code: RCI-8418
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 09/10/2019
  • Duration: 3 Months

  Job Description

 

 

Position:  Global GMP/GDP Compliance Contractor

  1. PURPOSE AND SCOPE OF POSITION

 

This position is responsible for managing and administering the Emerging/Changing Regulation Process, creating, revising and maintaining Quality Agreement templates and the development of a regulatory intelligence database to enable trending across client sites as well as across the industry.

 

  1. REQUIRED COMPETENCIES:

 

  • Must have broad knowledge of GMP/GDP and risk management.
  • Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the team.
  • Ability to complete routine tasks with no supervision. Confident in making non-routine decision in their subject matter area.  Able to work proactively. 
  • Drives continuous improvement and provides recommendations for improving efficiency and productivity of global compliance processes.

 

  1. DUTIES AND RESPONSIBILITIES:

 

  • The candidate will be responsible for managing the Global Emerging and Changing GMP/GDP Regulation and Guidance process as follows:
  • Must be able to coordinate change evaluations and comments and manage evaluation and comment documentation
  • Must be able to consolidate, write, and publish reports
  • Must be able to monitor and utilize regulatory intelligence to report external trends

 

  • The candidate will be responsible for the development, maintenance, routing and approval of Quality Agreement templates:
  • Must be able to route Quality Agreement templates for review and approval in the documentation management system
  • Must be able to implement requirements from new/revised regulations into the Quality Agreement templates
  • The candidate will be responsible for the creation of a regulatory intelligence database:
    • Must be able to prepare inspection-related reports upon request
    • Must be able to mine data from multiple sources (i.e., FDA, FDAzilla, etc.) to develop compliance trend reports