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

Planen Steuern Koordinieren Testen Berichten - Mein Angebot als Testmanager

Act

  • Manage project risks, additions and delays
  • Implement countermeasures

Plan

  • Project, budget and time planning
    Planning of the validation process
    Planning of documentation and test activities

Do

  • Create metrics to track the progress of the project
  • Create validation plans, risk analysis, and framework documentation
  • Perform validation activities (DQ, IQ, OQ, PQ)
  • Control the progress of the project

Report

  • Regular information on the progress of the project
  • Timely coordination on potential risks, additions or delays

Planen Steuern Koordinieren Testen Berichten - Mein Angebot als Testmanager

Check

  • Check compliance with legal requirements and good practice (GxP)
  • Verify coverage and maintain traceability of requirements
  • Monitoring the progress of the project

Project management and Test management

  • Budget-, resource- and time planning
  • Monitoring, control and communication of project progress
  • Lead of project teams
  • Creation of CSV documentation including
    Test Plan, FMEA, DQ, IQ, OQ, PQ, Traceability Matrix, Test Report
  • Create and perform (automated) black box and whitebox test cases

Quality Assurance Medical Devices

  • Quality assurance in accordance with FDA requirements 21 CFR Part 11 and 510K
  • Creation of test specifications and test scenarios according to product specifications, with a view to all possibilities and eventualities of interaction between device, program and device user
  • Execution and optimization of (also automated) test sequences beyond module and specification limits
  • Review of product specifications and programs

 

Validation of laboratory systems

  • Preparation of validation plans, risk analyses (FMEAs), qualification protocols (IQ, OQ, PQ), validation reports
  • CSV, GAMP 5
  • MES (Siemens)
  • LIMS (Labware)
  • Preactor Scheduler (Siemens)

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

You would like to know more about my services?
I am looking forward to your request.