IT Consultant Datamanagement, Quality Assurance, Testing and Validation
Aktualisiert am 03.07.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 02.07.2025
Verfügbar zu: 100%
davon vor Ort: 20%
LIMS
Software-Testing
Validierung
Computerized System Validation
Deutsch
Englisch
verhandlungssicher
Italienisch
erweiterte Grundkenntnisse
Französisch
Grundkenntnisse

Einsatzorte

Einsatzorte

Frankfurt am Main (+75km)
Deutschland
möglich

Projekte

Projekte

6 Jahre 2 Monate
2019-05 - 2025-06

Clinical Biomarker Operations

Consultant LIMS Computerized System Validation
Consultant
  • Creating and Updating of documentation
  • Extracting, transforming and loading biosample information from various datascoucres in Biosample Information Management System
  • Design and implementation of upload procedures to Biobanking Information Management System
  • Design and organization of supporting master data in Biosample Information Management System
  • Testing of procedures and logic of Biosample Information Management System to ensure proper excecution
Labvantage Veeva Vault HP-ALM Atlassian JIRA Cara Enterprise Content Services
LIMS Computerized System Validation
Darmstadt
1 Jahr 7 Monate
2023-06 - 2024-12

Re-Validation of Lab/Q Lims

LIMS Validation Expert LIMS Computerized System Validation Software-Testing
LIMS Validation Expert
  • Re-Validation of Lab/Q Lims
  • Creation and conduction OQ Testcases
  • Review of risk analyses and RTM
  • Writing, review and translation of SOPs
Lab/Q Lims
LIMS Computerized System Validation Software-Testing
Frankfurt am Main
8 Monate
2018-01 - 2018-08

OQ Test Script authoring and execution

Test Team Member GxP GxP-Compliance
Test Team Member
  • Design test strategy with reference to user requirements and functional specifications
  • Modular test approach
  • Parameterized test approach
  • consider risk assesment results for extent of test cases
  • explore MES development environment
  • author test scripts
  • maintain change control
  • review test scripts
MES SIMATIC IT Suites
GxP GxP-Compliance
Mainz
1 Jahr
2017-01 - 2017-12

Biobanking Project Phase II

Data Analyst LIMS
Data Analyst
  • Creating Testscripts according to GxP
  • Conducting Tests according to GxP
  • Consultancy in Masterdata and Data Import for Labvantage Platform
LabVantage 7
LIMS
Merck KGaA
Darmstadt
1 Jahr 10 Monate
2015-10 - 2017-07

PKPD New Business Model

project delivery management and technical lead
project delivery management and technical lead
  • project planning
  • stakeholder communication
  • installation qualification
  • application qualification
  • documentation and knowledge transfer
  • database migration
  • Phoenix/PKS configuration
  • SAS connection
Simcyp V14 (Certara) Phoenix 1.4 (Certara) PKS 4.0.3 (Certara)
Merck KGaA
Darmstadt
7 Monate
2016-06 - 2016-12

Biosample Management OQ Testing Phase I

Operational Qualification Manager LIMS
Operational Qualification Manager
  • Create OQ Testscripts according to GxP
  • Conduct formal OQ-Test according to GxP
  • Consultancy in Masterdata and DAta Import for Labvantage Platform

LabVantage
LIMS
Merck KGaA
Darmstadt
2 Monate
2014-04 - 2014-05

Technical Refresh of GRED Application

delivery management and technical lead
delivery management and technical lead
  • Migration of Spotfire V 4.5 to V6 including testing, incidence and problem management
Spotfire (Tibco)
Merck KGaA
Darmstadt
9 Monate
2013-04 - 2013-12

Support and consulting services for research applications

3rd level support, service delivery support
3rd level support, service delivery support
  • system management Luxid and Spotfire
  • Designs, tests, implements backup, recovery procedures
  • incident and problem management
  • software installations, creations / configurations, and loads
  • patch rollout
  • Reporting on the progress of the functional and end-to-end tests 
  • study migration new PKPD system
  • project support new PKPD (Phoenix WinNonlin)
  • Luxid annotation support
  • knowledge transfer Luxid
Luxid (Temis) Phoenix 1.3 PKS 4.0.3 Spotfire 4.5
Merck KGaA
Darmstadt
3 Monate
2013-01 - 2013-03

IT-Service Delivery Support for Luxid

3rd level Support, Service delivery support
3rd level Support, Service delivery support
  • Knowledge Transfer to assigned Service Delivery Manager
  • Responsible for the management of assigned systems
  • 3rd Level maintenance support
  • Designs, tests, implements backup, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
Luxid
merck KGaM
Darmstadt
2 Monate
2012-11 - 2012-12

IT-Support for project ?new PKPD System?

3rd level support, support service delivery
3rd level support, support service delivery
  • Responsible for the management of assigned systems
  • Designs, tests, implements backup, recovery and restart procedures
  • Responsible for incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
  • End-to-end management of the project in terms of organisation, time, budget, information and quality control
  • Reporting on the progress of the functional and end-to-end tests in consultation with the analyst and test adviser
Phoenix 1.2
Merck KGaA
Darmstadt
6 Monate
2012-07 - 2012-12

IT-Service Delivery Support

3rd Level Support
3rd Level Support
  • Responsible for the management of assigned systems
  • 3rd Level maintenance support pharma applications
  • Designs, tests, implements backup, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
  • Support of application trainings
  • Upgrade Spotfire 3.3.1 to 4.5
Luxid Spotfire
Merck KGaA
Darmstadt
3 Monate
2012-08 - 2012-10

IT-Service Delivery Support for Upgrade Luxid 5.2 to Luxid 6.0

3rd level Support, Service Delivery Support
3rd level Support, Service Delivery Support
  • Responsible for the management of assigned systems
  • 3rd Level maintenance support pharma applications
  • Designs, tests, implements backup, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations
Luxid 6.0
Merck KGaA
Darmstadt
6 Monate
2012-01 - 2012-06

application support 2nd/3rd level and release and upgrade projects

3rd Level Support
3rd Level Support
  • Responsible for the management of assigned systems
  • 3rd Level maintenance support pharma applications
  • Designs, tests, implements backup, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
Luxid Spotfire
Merck KGaA
Darmstadt
6 Monate
2011-07 - 2011-12

IT Service Delivery Support Luxid and Spotfire

3rd Level Support, Service Delivery Support
3rd Level Support, Service Delivery Support
  • Responsible for the management of assigned systems
  • 3rd Level maintenance support pharma applications
  • Designs, tests, and implements back up, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
  • Support of application trainings
  • Upgrade Spotfire 3.2.0 to 3.3.1
Spotfire Luxid
Merck KGaA
Darmstadt
6 Monate
2011-01 - 2011-06

3rd Level Maintenance Support Pharma, SDM Support

  • Responsible for the management of assigned systems
  • 3rd Level maintenance support pharma applications
  • Designs, tests, and implements back up, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
  • Support of application trainings
Spotfire Luxid
1 Jahr
2010-07 - 2011-06

TIBCO Spotfire Migration

Project Manager
Project Manager
  • End-to-end management of the project in terms of organisation, time, budget, information and quality control
  • Providing project-based direction and coaching to the project team members
  • Reporting on the progress of the functional and end-to-end tests in consultation with the analyst and test adviser
  • Ensuring correct delivery of the project in accordance with the release process. Acting as contact for dealing with
    fixes during the warranty period
TIBCO Spotfire 3.2.0
Merck KGaA
Darmstadt
6 Monate
2010-07 - 2010-12

3rd level maintenance support Pharma application

3rd Level Support, SDM Support
3rd Level Support, SDM Support
  • Responsible for the management of assigned systems
  • 3rd Level maintenance support pharma applications
  • Designs, tests, and implements back up, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
  • Support of application trainings
Spotfire Luxid
Merck KGaA
Darmstadt

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Monat
2018-11 - 2018-11

ISTQB Certified Tester Foundation Level

ISTQB Certified Tester Zertifikatsnr. 18-CTFL-146899-01, International Software Quality Institute
ISTQB Certified Tester Zertifikatsnr. 18-CTFL-146899-01
International Software Quality Institute
  • Grundlagen des Softwarestens
  • Testen im Softwarelebenszyklus
  • Statischer Test
  • Testentwurfsverfahren
  • Testmangement
  • Testwerkzeuge
1 Monat
2016-09 - 2016-09

Labvantage 7 Administration

Certificate of Achivement, Labvantage
Certificate of Achivement
Labvantage

Labvantage 7 Administration

1 Monat
2009-09 - 2009-09

ITIL Version 2 Foundation Examination

successfully participated, TÜV Süd Akademie
successfully participated
TÜV Süd Akademie
1 Jahr 1 Monat
2002-10 - 2003-10

IT Sicherheit

Zertifikat IT-Sicherheit, Technische Universität Darmstadt
Zertifikat IT-Sicherheit
Technische Universität Darmstadt
  • IT-Sicherheit
  • Mobile Sicherheit
  • Einführung in die Kryptographie
  • VPN-Virtual Private Networks
  • IT-Sicherheit II
  • IT-Sicherheitsmanagement
  • Public-Key-Infrastrukturen
  • Digitale Wasserzeichen

Kompetenzen

Kompetenzen

Top-Skills

LIMS Software-Testing Validierung Computerized System Validation

Produkte / Standards / Erfahrungen / Methoden

LabVantage
LabVantage 7
LIMS
MES SIMATIC IT Suites
Phoenix 1.4 (Certara)
PKS 4.0.3 (Certara)
Simcyp V14 (Certara)
Spotfire
Spotfire (Tibco)


Beruflicher Werdegang:

ab 2001

  • Freiberufler im Umfeld IT- und Telekommunikationstechnik

1995-2000

  • Unternehmensgründung und Geschäftsführung der [Name auf Anfrage]
  • Unternehmensinhalt: Consulting und Softwareentwicklung in den Bereichen Archiving, Dokumenten Management Systeme, Web Content Management,Publishing und Imaging
  • Verantwortlichkeiten: IT-Organisation, Office-Coordinaton und Personalwesen

 

1993-1995

  • freiberuflicher IT-Support und Programmierung
  • Branche: Pharmaindustrie
  • Bereich: klinische Forschung

Betriebssysteme

64Bit-Betriebssysteme
Enterprise Linux
Windows Administration

Programmiersprachen

Assembler
Grundkenntnisse
Basic
Grundkenntnisse
C
Grundkenntnisse
C++
Grundkenntnisse
Fortran
Grundkenntnisse
Java
Pascal
Grundkenntnisse
PHP

Datenbanken

MS SQL Server
Grundkenntnisse
MySQL
sicher
ODBC
Grundkenntnisse
Oracle
vertiefte Kenntnisse
Pervasive PSQL
sicher

Datenkommunikation

DFS
Ethernet
Fax
HTTP
HTTPS
Internet, Intranet
ISDN
NetBeui
NetBios
parallele Schnittstelle
PC-Anywhere
Router
SMTP
TCP/IP
UMS (Unified Messaging Systems)
Windows Netzwerk
Winsock

Berechnung / Simulation / Versuch / Validierung

GxP
GxP-Compliance
MES SIMATIC IT Suites

Branchen

Branchen

Pharma

Einsatzorte

Einsatzorte

Frankfurt am Main (+75km)
Deutschland
möglich

Projekte

Projekte

6 Jahre 2 Monate
2019-05 - 2025-06

Clinical Biomarker Operations

Consultant LIMS Computerized System Validation
Consultant
  • Creating and Updating of documentation
  • Extracting, transforming and loading biosample information from various datascoucres in Biosample Information Management System
  • Design and implementation of upload procedures to Biobanking Information Management System
  • Design and organization of supporting master data in Biosample Information Management System
  • Testing of procedures and logic of Biosample Information Management System to ensure proper excecution
Labvantage Veeva Vault HP-ALM Atlassian JIRA Cara Enterprise Content Services
LIMS Computerized System Validation
Darmstadt
1 Jahr 7 Monate
2023-06 - 2024-12

Re-Validation of Lab/Q Lims

LIMS Validation Expert LIMS Computerized System Validation Software-Testing
LIMS Validation Expert
  • Re-Validation of Lab/Q Lims
  • Creation and conduction OQ Testcases
  • Review of risk analyses and RTM
  • Writing, review and translation of SOPs
Lab/Q Lims
LIMS Computerized System Validation Software-Testing
Frankfurt am Main
8 Monate
2018-01 - 2018-08

OQ Test Script authoring and execution

Test Team Member GxP GxP-Compliance
Test Team Member
  • Design test strategy with reference to user requirements and functional specifications
  • Modular test approach
  • Parameterized test approach
  • consider risk assesment results for extent of test cases
  • explore MES development environment
  • author test scripts
  • maintain change control
  • review test scripts
MES SIMATIC IT Suites
GxP GxP-Compliance
Mainz
1 Jahr
2017-01 - 2017-12

Biobanking Project Phase II

Data Analyst LIMS
Data Analyst
  • Creating Testscripts according to GxP
  • Conducting Tests according to GxP
  • Consultancy in Masterdata and Data Import for Labvantage Platform
LabVantage 7
LIMS
Merck KGaA
Darmstadt
1 Jahr 10 Monate
2015-10 - 2017-07

PKPD New Business Model

project delivery management and technical lead
project delivery management and technical lead
  • project planning
  • stakeholder communication
  • installation qualification
  • application qualification
  • documentation and knowledge transfer
  • database migration
  • Phoenix/PKS configuration
  • SAS connection
Simcyp V14 (Certara) Phoenix 1.4 (Certara) PKS 4.0.3 (Certara)
Merck KGaA
Darmstadt
7 Monate
2016-06 - 2016-12

Biosample Management OQ Testing Phase I

Operational Qualification Manager LIMS
Operational Qualification Manager
  • Create OQ Testscripts according to GxP
  • Conduct formal OQ-Test according to GxP
  • Consultancy in Masterdata and DAta Import for Labvantage Platform

LabVantage
LIMS
Merck KGaA
Darmstadt
2 Monate
2014-04 - 2014-05

Technical Refresh of GRED Application

delivery management and technical lead
delivery management and technical lead
  • Migration of Spotfire V 4.5 to V6 including testing, incidence and problem management
Spotfire (Tibco)
Merck KGaA
Darmstadt
9 Monate
2013-04 - 2013-12

Support and consulting services for research applications

3rd level support, service delivery support
3rd level support, service delivery support
  • system management Luxid and Spotfire
  • Designs, tests, implements backup, recovery procedures
  • incident and problem management
  • software installations, creations / configurations, and loads
  • patch rollout
  • Reporting on the progress of the functional and end-to-end tests 
  • study migration new PKPD system
  • project support new PKPD (Phoenix WinNonlin)
  • Luxid annotation support
  • knowledge transfer Luxid
Luxid (Temis) Phoenix 1.3 PKS 4.0.3 Spotfire 4.5
Merck KGaA
Darmstadt
3 Monate
2013-01 - 2013-03

IT-Service Delivery Support for Luxid

3rd level Support, Service delivery support
3rd level Support, Service delivery support
  • Knowledge Transfer to assigned Service Delivery Manager
  • Responsible for the management of assigned systems
  • 3rd Level maintenance support
  • Designs, tests, implements backup, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
Luxid
merck KGaM
Darmstadt
2 Monate
2012-11 - 2012-12

IT-Support for project ?new PKPD System?

3rd level support, support service delivery
3rd level support, support service delivery
  • Responsible for the management of assigned systems
  • Designs, tests, implements backup, recovery and restart procedures
  • Responsible for incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
  • End-to-end management of the project in terms of organisation, time, budget, information and quality control
  • Reporting on the progress of the functional and end-to-end tests in consultation with the analyst and test adviser
Phoenix 1.2
Merck KGaA
Darmstadt
6 Monate
2012-07 - 2012-12

IT-Service Delivery Support

3rd Level Support
3rd Level Support
  • Responsible for the management of assigned systems
  • 3rd Level maintenance support pharma applications
  • Designs, tests, implements backup, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
  • Support of application trainings
  • Upgrade Spotfire 3.3.1 to 4.5
Luxid Spotfire
Merck KGaA
Darmstadt
3 Monate
2012-08 - 2012-10

IT-Service Delivery Support for Upgrade Luxid 5.2 to Luxid 6.0

3rd level Support, Service Delivery Support
3rd level Support, Service Delivery Support
  • Responsible for the management of assigned systems
  • 3rd Level maintenance support pharma applications
  • Designs, tests, implements backup, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations
Luxid 6.0
Merck KGaA
Darmstadt
6 Monate
2012-01 - 2012-06

application support 2nd/3rd level and release and upgrade projects

3rd Level Support
3rd Level Support
  • Responsible for the management of assigned systems
  • 3rd Level maintenance support pharma applications
  • Designs, tests, implements backup, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
Luxid Spotfire
Merck KGaA
Darmstadt
6 Monate
2011-07 - 2011-12

IT Service Delivery Support Luxid and Spotfire

3rd Level Support, Service Delivery Support
3rd Level Support, Service Delivery Support
  • Responsible for the management of assigned systems
  • 3rd Level maintenance support pharma applications
  • Designs, tests, and implements back up, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
  • Support of application trainings
  • Upgrade Spotfire 3.2.0 to 3.3.1
Spotfire Luxid
Merck KGaA
Darmstadt
6 Monate
2011-01 - 2011-06

3rd Level Maintenance Support Pharma, SDM Support

  • Responsible for the management of assigned systems
  • 3rd Level maintenance support pharma applications
  • Designs, tests, and implements back up, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
  • Support of application trainings
Spotfire Luxid
1 Jahr
2010-07 - 2011-06

TIBCO Spotfire Migration

Project Manager
Project Manager
  • End-to-end management of the project in terms of organisation, time, budget, information and quality control
  • Providing project-based direction and coaching to the project team members
  • Reporting on the progress of the functional and end-to-end tests in consultation with the analyst and test adviser
  • Ensuring correct delivery of the project in accordance with the release process. Acting as contact for dealing with
    fixes during the warranty period
TIBCO Spotfire 3.2.0
Merck KGaA
Darmstadt
6 Monate
2010-07 - 2010-12

3rd level maintenance support Pharma application

3rd Level Support, SDM Support
3rd Level Support, SDM Support
  • Responsible for the management of assigned systems
  • 3rd Level maintenance support pharma applications
  • Designs, tests, and implements back up, recovery and restart procedures
  • Responsible for changes, incident handling and problem solving
  • Executes software installations, creations / configurations, and loads
  • Support of application trainings
Spotfire Luxid
Merck KGaA
Darmstadt

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Monat
2018-11 - 2018-11

ISTQB Certified Tester Foundation Level

ISTQB Certified Tester Zertifikatsnr. 18-CTFL-146899-01, International Software Quality Institute
ISTQB Certified Tester Zertifikatsnr. 18-CTFL-146899-01
International Software Quality Institute
  • Grundlagen des Softwarestens
  • Testen im Softwarelebenszyklus
  • Statischer Test
  • Testentwurfsverfahren
  • Testmangement
  • Testwerkzeuge
1 Monat
2016-09 - 2016-09

Labvantage 7 Administration

Certificate of Achivement, Labvantage
Certificate of Achivement
Labvantage

Labvantage 7 Administration

1 Monat
2009-09 - 2009-09

ITIL Version 2 Foundation Examination

successfully participated, TÜV Süd Akademie
successfully participated
TÜV Süd Akademie
1 Jahr 1 Monat
2002-10 - 2003-10

IT Sicherheit

Zertifikat IT-Sicherheit, Technische Universität Darmstadt
Zertifikat IT-Sicherheit
Technische Universität Darmstadt
  • IT-Sicherheit
  • Mobile Sicherheit
  • Einführung in die Kryptographie
  • VPN-Virtual Private Networks
  • IT-Sicherheit II
  • IT-Sicherheitsmanagement
  • Public-Key-Infrastrukturen
  • Digitale Wasserzeichen

Kompetenzen

Kompetenzen

Top-Skills

LIMS Software-Testing Validierung Computerized System Validation

Produkte / Standards / Erfahrungen / Methoden

LabVantage
LabVantage 7
LIMS
MES SIMATIC IT Suites
Phoenix 1.4 (Certara)
PKS 4.0.3 (Certara)
Simcyp V14 (Certara)
Spotfire
Spotfire (Tibco)


Beruflicher Werdegang:

ab 2001

  • Freiberufler im Umfeld IT- und Telekommunikationstechnik

1995-2000

  • Unternehmensgründung und Geschäftsführung der [Name auf Anfrage]
  • Unternehmensinhalt: Consulting und Softwareentwicklung in den Bereichen Archiving, Dokumenten Management Systeme, Web Content Management,Publishing und Imaging
  • Verantwortlichkeiten: IT-Organisation, Office-Coordinaton und Personalwesen

 

1993-1995

  • freiberuflicher IT-Support und Programmierung
  • Branche: Pharmaindustrie
  • Bereich: klinische Forschung

Betriebssysteme

64Bit-Betriebssysteme
Enterprise Linux
Windows Administration

Programmiersprachen

Assembler
Grundkenntnisse
Basic
Grundkenntnisse
C
Grundkenntnisse
C++
Grundkenntnisse
Fortran
Grundkenntnisse
Java
Pascal
Grundkenntnisse
PHP

Datenbanken

MS SQL Server
Grundkenntnisse
MySQL
sicher
ODBC
Grundkenntnisse
Oracle
vertiefte Kenntnisse
Pervasive PSQL
sicher

Datenkommunikation

DFS
Ethernet
Fax
HTTP
HTTPS
Internet, Intranet
ISDN
NetBeui
NetBios
parallele Schnittstelle
PC-Anywhere
Router
SMTP
TCP/IP
UMS (Unified Messaging Systems)
Windows Netzwerk
Winsock

Berechnung / Simulation / Versuch / Validierung

GxP
GxP-Compliance
MES SIMATIC IT Suites

Branchen

Branchen

Pharma

Vertrauen Sie auf Randstad

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Im Bereich Arbeitnehmerüberlassung / Personalvermittlung

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