Consultant Data Integrity (m/f)

REFERENZNUMMER:

308622/3

IHRE AUFGABEN:

-Evaluate and develop action plan for the quality issues together with the data integrity community
-Build and lead data integrity community
-Implement actions from the action plan, prepare possible changes, adapt and create local SOPs, work instructions
-Perform gap analysis together with the site matter experts of the departments, evaluate the risk and create action plan
-Create a monthly communication package of the current status of the site risk
-Educate SMEs of the area with regard to data integrity
-Support level 2 inspection for creation with focus on data integrity

IHRE QUALIFIKATIONEN:

-Profound knowledge of a pharmaceutical quality management system, particularly GxP compliant documentation and validation of computerized systems
-Profound experience in the pharmaceutical industry, especially with the GxP documentation
-Good understanding of and interest in IT systems and processes, as well as network and system architectures
-Competent handling of MS Windows 7, MS Office 2010, MS Project 2010

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist