EN Website

Certified Test Manager (ISTQB)
Certified Project Manager (IHK)

EN Website

Certified Test Manager (ISTQB)
Certified Project Manager (IHK)

"Project success with team spirit, experience and a good understanding"

Validation and test management

  • Validation management incl. planning,
    execution and reporting
  • Creation of risk assessments and traceability matrices
  • Supplier qualification
  • Test management incl. planning, execution, report generation
  • Risk-based creation of test specifications and (automated) test cases
  • Test execution and evaluation documentation incl. deviation reports

Quality Assurance

  • Quality assurance in a regulated environment
  • Requirements management
  • Business continuity management and disaster recovery
  • Standard Operating Procedures
  • Legal requirements EudraLex Vol.4 GMP, AMG, AMWHV, FDA 21 CFR Part 211 (CGMP), Part 11 (Compliance & Validation)

 

Data Integrity Management

  • Coordinate measures to achieve data integrity
  • Create data integrity documents e.g. questionnaires and checklists
  • Create and visualize process flow diagrams and data flow analyses
  • Acquire data integrity of processes and computerized systems
  • Review gaps towards FDA and GxP compliance
  • Determine implementation of measures to mitigate existing risks

Project languages

German
English
(fluent, business fluent)

Locations

Prefers Mannheim and 100 km surroundings - other locations and foreign countries on request.

kontakt@jens-burkert.de

I am looking forward to your request!