Description
We are looking for a
Consultant Data Integrity (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in Saxony
Branch: Forschungsinstitute
Your tasks:
- 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
Your qualifications
- 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
Skills:
- Qualification/validation specialist
Keywords: Validierung Qualifizierung