Jens Burkert - My Services - Jens Burkert

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

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

"Project success through team spirit, experience, and insight"

Validation and test management

Validation management incl. planning,
execution and reporting
Managing the end-to-end documentation lifecycle (requirements/URS to validation report)
Creation of risk assessments and traceability matrices

Test management including planning, execution, report generation
Risk-based creation of test specifications and (automated) test cases
Test implementation and evaluation documentation including deviation reports

Quality Assurance

Quality assurance in a regulated environment
Business continuity management and disaster recovery
Work instructions, standard operating procedures
Requirements management
Legal requirements EudraLex Vol. 4 GMP, FDA 21 CFR Part 11 (compliance & validation)

Data Integrity Management

Coordinate measures to achieve data integrity
Create data integrity documents, questionnaires and checklists
Create process flow diagrams and data flow analyses
Acquire data integrity of processes and computerized systems
Check for gaps in FDA and GxP compliance and 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!