- Title: Compliance Administrator
- Code: RCI-8418
- Location: Summit New Jersey (NJ) 07901
- Posted Date: 09/10/2019
- Duration: 3 Months
Position: Global GMP/GDP Compliance Contractor
- 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.
- 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.
- 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