Quality Management Officer, Computerized System Validation Officer (CSV),Quality Assurance
Aktualisiert am 18.12.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.02.2026
Verfügbar zu: 100%
davon vor Ort: 50%
CSV
QM
QA
Qualitätssicherung
Qualitymanagement
Computerized System Validation
CAPA
Abweichungen
Qmb
Changemanagement
Change Request Management
Good Manufacturing Practice
Good Distribution Practice
QMS
QMB
DEVIATION
German
native
English
business fluent
Albanian
native

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

6 Monate
2025-07 - heute

Developed and implemented a comprehensive CSV strategy

Quality Assurance Expert/Consultant
Quality Assurance Expert/Consultant
  • Developed and implemented a comprehensive CSV strategy, including SOPs, templates, and risk-based validation approaches aligned with EU GMP Annex 11, 21 CFR Part 11, and GAMP 5 requirements.
  • Led the revision and harmonization of QMS processes, ensuring consistency across Change Control, CAPA Management, Deviation Management, 3rd Party Qualification aligned with current applicable regulatory standards.
  • Revised and optimized the Quality Risk Management strategy, integrating it into validation and qualification activities to enhance system compliance and lifecycle control.
  • Reviewed and ensured compliance of global validation documentation, focusing on site-specific risk assessment and regulatory impact for local implementation.
Recordati Pharma GmbH
Ulm
9 Monate
2024-11 - 2025-07

Revision and optimization of the existing CAPA concept

Quality Systems Consultant
Quality Systems Consultant
  • Consulted on the optimization of the Change Control Management Deviation, and Lab Investigation concepts, including definition of required employee qualifications.
  • Led the revision and optimization of the existing CAPA concept within the QMS.
  • Created Work Instructions (WIs) for Deviation Management, CAPA Management, Lab Investigations, Reporting, and Trending to support the new Veeva implementation.
  • Conducted user training for the newly migrated and implemented Veeva QMS processes.
Teva Biotech GmbH
Ulm
11 Monate
2023-08 - 2024-06

Laboratory Information Management System

Business Systems Analyst
Business Systems Analyst
Laboratory Information Management System (LabVantage) Global Implementation
  • Led the analysis and documentation of laboratory workflows and requirements for the LIMS implementation across 5 Business Units and 2 Analytic labs.
  • Implemented Master Data Management (MDM) strategies within LIMS to ensure centralized governance, standardization, and integrity of critical laboratory data.
  •  Developed and executed comprehensive project plans for LIMS implementation, covering data migration, system configuration, and user training.
  • Elicited functional specifications and user requirements for LIMS modules, including instrument integration and data exchange interfaces.
  • Managed SDLC activities (e.g., test script development and execution) to guarantee LIMS compliance with user requirements and industry standards.
BioNTech SE
Mainz
6 Monate
2023-02 - 2023-07

Laboratory Information Management System

Business Systems Analyst
Business Systems Analyst
Laboratory Information Management System (LabVantage) Global Implementation
  • Led the analysis and documentation of laboratory workflows and requirements for the LIMS implementation across 5 Business Units and 2 Analytic labs.
  • Implemented Master Data Management (MDM) strategies within LIMS to ensure centralized governance, standardization, and integrity of critical laboratory data.
  • Developed and executed comprehensive project plans for LIMS implementation, covering data migration, system configuration, and user training.
  • Elicited functional specifications and user requirements for LIMS modules, including instrument integration and data exchange interfaces.
  • Managed SDLC activities (e.g., test script development and execution) to guarantee LIMS compliance with user requirements and industry standards.
BioNTech SE
Mainz
11 Monate
2022-03 - 2023-01

GxP Application Management Consultation

CSV Consultant
CSV Consultant
GxP Application Management Consultation for QA, QC and Business (Labware)
  • Managed Change Control processes for IT systems to ensure compliant configuration and system releases.
  • Defined Validation Strategies (Re-validation) for QMS systems, meeting 21 CFR Part 11, EU GMP Annex 11.
  • Developed and maintained comprehensive Validation Lifecycle Documentation and Templates.
  • Coordinated qualification testing phases (DQ, IQ, OQ, PQ/UAT).
  • Maintained LIMS Master Data and ensured Data Integrity compliance following ALCOA+ principles.
BioNTech SE
Mainz
1 Jahr 7 Monate
2021-06 - 2022-12

SAP -MM/QM Implementation for R&D

  • Managed the full lifecycle of Change Management for regulated applications.
  • Provided expert consultation on System Release Planning and Execution.
  • Executed Process/Gap Analyses and successfully drove resulting improvements.
  • Delivered System Engineering services for GxP and non-GxP environments.
Sanofi
Frankfurt
6 Monate
2021-12 - 2022-05

Coordination of the IQ/OQ/PQ phases and management

CSV Engineer| Quality and Compliance Consultant
CSV Engineer| Quality and Compliance Consultant
  • Solution-oriented consultation of cross-functional teams with central CSV Subject Matter Expertise (SME).
  • Responsibility for the Validation Strategy and successful delivery of six CSV projects within the GxP environment.
  • Coordination of the IQ/OQ/PQ phases and management of the CAPA process under 21 CFR Part 11 / Annex 11.
Karl Storz
Tuttlingen
1 Jahr 3 Monate
2020-04 - 2021-06

Monitoring, development, and optimization of production processes

Chemical Engineer
Chemical Engineer
Monitoring, development, and optimization of production processes and direct report to CTO
  • Process development and optimization
  • Equipment qualification/ validation
  • Stakeholder requirements engineer, project management, and strategic planning
  • Monitoring of ISO-compliant working atmosphere ISO 14644
  • Simulation using freeCAD and SalomeMeca
NanoWired GmbH
Gernsheim
1 Jahr 8 Monate
2018-02 - 2019-09

production control, booking, and checking production orders

Chemical Production Engineer
Chemical Production Engineer
working in the supply chain of production and supporting the production control
? Supporting the production control, booking, and checking production orders
? Verifying compatibility of different chemicals
? Verifying the consistency in the range of the production process
? Determine concentrations of chemicals and adjusting the process if needed
Merk KGaA
Frankfurt

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Monat
2025-11 - 2025-11

Computerized Systems Validation (CSV) Officer

CSV Officer, Concept Heidelberg
CSV Officer
Concept Heidelberg
  • Regulatory framework and lifecycle approach for computerized systems
  • Roles and responsibilities of the CSV Officer within a QMS
  • Risk-based validation strategy and application of GAMP 5 principles
  • Preparation and review of key validation deliverables (URS, RA, IQ/OQ/PQ, Traceability Matrix)
  • Data integrity and audit trail review
  • Change control, deviation, and periodic review management for validated systems
  • Supplier qualification and assessment of software vendors
1 Monat
2024-09 - 2024-09

Quality Management Officer

TÜV Süd
TÜV Süd
  • ISO 9001
  • SWOT, Ishikawa, 5Why, Pareto
  • FMEA, 8D, QFD
  • Statistics
  • Audits, Supplier-, Error- and Customer management
3 Jahre 5 Monate
2012-10 - 2016-02

Engineering

Chemical Engineer, Bachelor of Engineering, University of Applied Sciences - Darmstadt
Chemical Engineer, Bachelor of Engineering
University of Applied Sciences - Darmstadt
  • Physical Chemistry
  • Nanotechnologies
2 Jahre 3 Monate
2009-07 - 2011-09

Community Service (Zivildienst)

Klinikum Frankfurt Höchst
Klinikum Frankfurt Höchst
Assisting in the provision of all medical consumables and devices in compliance with safety and hygiene standards

Position

Position

Quality and Compliance Consultant

Kompetenzen

Kompetenzen

Top-Skills

CSV QM QA Qualitätssicherung Qualitymanagement Computerized System Validation CAPA Abweichungen Qmb Changemanagement Change Request Management Good Manufacturing Practice Good Distribution Practice QMS QMB DEVIATION

Produkte / Standards / Erfahrungen / Methoden

Skills

  • GAMP
  • GAMP 5
  • Computer System Validation (CSV)
  • Data Integrity
  • ISO 14971
  • ISO 13485
  • ISO 9001
  • BPMN 2.0
  • ISO 14001
  • ISO 19011
  • GxP
  • SAP
  • ALCOA+
  • Change Management
  • Deviations
  • CAPA


COMPETENCIES

  • Team Work
  • Creativity
  • Communication
  • Self Sufficiency
  • Problem solving


Work Experience

09/2014 - 11/2015

Role: Working Student for Quality Control 

Customer: Kuraray Europe GmbH


Tasks:

Testing according to test instructions, evaluation of data, and documentation

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

6 Monate
2025-07 - heute

Developed and implemented a comprehensive CSV strategy

Quality Assurance Expert/Consultant
Quality Assurance Expert/Consultant
  • Developed and implemented a comprehensive CSV strategy, including SOPs, templates, and risk-based validation approaches aligned with EU GMP Annex 11, 21 CFR Part 11, and GAMP 5 requirements.
  • Led the revision and harmonization of QMS processes, ensuring consistency across Change Control, CAPA Management, Deviation Management, 3rd Party Qualification aligned with current applicable regulatory standards.
  • Revised and optimized the Quality Risk Management strategy, integrating it into validation and qualification activities to enhance system compliance and lifecycle control.
  • Reviewed and ensured compliance of global validation documentation, focusing on site-specific risk assessment and regulatory impact for local implementation.
Recordati Pharma GmbH
Ulm
9 Monate
2024-11 - 2025-07

Revision and optimization of the existing CAPA concept

Quality Systems Consultant
Quality Systems Consultant
  • Consulted on the optimization of the Change Control Management Deviation, and Lab Investigation concepts, including definition of required employee qualifications.
  • Led the revision and optimization of the existing CAPA concept within the QMS.
  • Created Work Instructions (WIs) for Deviation Management, CAPA Management, Lab Investigations, Reporting, and Trending to support the new Veeva implementation.
  • Conducted user training for the newly migrated and implemented Veeva QMS processes.
Teva Biotech GmbH
Ulm
11 Monate
2023-08 - 2024-06

Laboratory Information Management System

Business Systems Analyst
Business Systems Analyst
Laboratory Information Management System (LabVantage) Global Implementation
  • Led the analysis and documentation of laboratory workflows and requirements for the LIMS implementation across 5 Business Units and 2 Analytic labs.
  • Implemented Master Data Management (MDM) strategies within LIMS to ensure centralized governance, standardization, and integrity of critical laboratory data.
  •  Developed and executed comprehensive project plans for LIMS implementation, covering data migration, system configuration, and user training.
  • Elicited functional specifications and user requirements for LIMS modules, including instrument integration and data exchange interfaces.
  • Managed SDLC activities (e.g., test script development and execution) to guarantee LIMS compliance with user requirements and industry standards.
BioNTech SE
Mainz
6 Monate
2023-02 - 2023-07

Laboratory Information Management System

Business Systems Analyst
Business Systems Analyst
Laboratory Information Management System (LabVantage) Global Implementation
  • Led the analysis and documentation of laboratory workflows and requirements for the LIMS implementation across 5 Business Units and 2 Analytic labs.
  • Implemented Master Data Management (MDM) strategies within LIMS to ensure centralized governance, standardization, and integrity of critical laboratory data.
  • Developed and executed comprehensive project plans for LIMS implementation, covering data migration, system configuration, and user training.
  • Elicited functional specifications and user requirements for LIMS modules, including instrument integration and data exchange interfaces.
  • Managed SDLC activities (e.g., test script development and execution) to guarantee LIMS compliance with user requirements and industry standards.
BioNTech SE
Mainz
11 Monate
2022-03 - 2023-01

GxP Application Management Consultation

CSV Consultant
CSV Consultant
GxP Application Management Consultation for QA, QC and Business (Labware)
  • Managed Change Control processes for IT systems to ensure compliant configuration and system releases.
  • Defined Validation Strategies (Re-validation) for QMS systems, meeting 21 CFR Part 11, EU GMP Annex 11.
  • Developed and maintained comprehensive Validation Lifecycle Documentation and Templates.
  • Coordinated qualification testing phases (DQ, IQ, OQ, PQ/UAT).
  • Maintained LIMS Master Data and ensured Data Integrity compliance following ALCOA+ principles.
BioNTech SE
Mainz
1 Jahr 7 Monate
2021-06 - 2022-12

SAP -MM/QM Implementation for R&D

  • Managed the full lifecycle of Change Management for regulated applications.
  • Provided expert consultation on System Release Planning and Execution.
  • Executed Process/Gap Analyses and successfully drove resulting improvements.
  • Delivered System Engineering services for GxP and non-GxP environments.
Sanofi
Frankfurt
6 Monate
2021-12 - 2022-05

Coordination of the IQ/OQ/PQ phases and management

CSV Engineer| Quality and Compliance Consultant
CSV Engineer| Quality and Compliance Consultant
  • Solution-oriented consultation of cross-functional teams with central CSV Subject Matter Expertise (SME).
  • Responsibility for the Validation Strategy and successful delivery of six CSV projects within the GxP environment.
  • Coordination of the IQ/OQ/PQ phases and management of the CAPA process under 21 CFR Part 11 / Annex 11.
Karl Storz
Tuttlingen
1 Jahr 3 Monate
2020-04 - 2021-06

Monitoring, development, and optimization of production processes

Chemical Engineer
Chemical Engineer
Monitoring, development, and optimization of production processes and direct report to CTO
  • Process development and optimization
  • Equipment qualification/ validation
  • Stakeholder requirements engineer, project management, and strategic planning
  • Monitoring of ISO-compliant working atmosphere ISO 14644
  • Simulation using freeCAD and SalomeMeca
NanoWired GmbH
Gernsheim
1 Jahr 8 Monate
2018-02 - 2019-09

production control, booking, and checking production orders

Chemical Production Engineer
Chemical Production Engineer
working in the supply chain of production and supporting the production control
? Supporting the production control, booking, and checking production orders
? Verifying compatibility of different chemicals
? Verifying the consistency in the range of the production process
? Determine concentrations of chemicals and adjusting the process if needed
Merk KGaA
Frankfurt

Aus- und Weiterbildung

Aus- und Weiterbildung

1 Monat
2025-11 - 2025-11

Computerized Systems Validation (CSV) Officer

CSV Officer, Concept Heidelberg
CSV Officer
Concept Heidelberg
  • Regulatory framework and lifecycle approach for computerized systems
  • Roles and responsibilities of the CSV Officer within a QMS
  • Risk-based validation strategy and application of GAMP 5 principles
  • Preparation and review of key validation deliverables (URS, RA, IQ/OQ/PQ, Traceability Matrix)
  • Data integrity and audit trail review
  • Change control, deviation, and periodic review management for validated systems
  • Supplier qualification and assessment of software vendors
1 Monat
2024-09 - 2024-09

Quality Management Officer

TÜV Süd
TÜV Süd
  • ISO 9001
  • SWOT, Ishikawa, 5Why, Pareto
  • FMEA, 8D, QFD
  • Statistics
  • Audits, Supplier-, Error- and Customer management
3 Jahre 5 Monate
2012-10 - 2016-02

Engineering

Chemical Engineer, Bachelor of Engineering, University of Applied Sciences - Darmstadt
Chemical Engineer, Bachelor of Engineering
University of Applied Sciences - Darmstadt
  • Physical Chemistry
  • Nanotechnologies
2 Jahre 3 Monate
2009-07 - 2011-09

Community Service (Zivildienst)

Klinikum Frankfurt Höchst
Klinikum Frankfurt Höchst
Assisting in the provision of all medical consumables and devices in compliance with safety and hygiene standards

Position

Position

Quality and Compliance Consultant

Kompetenzen

Kompetenzen

Top-Skills

CSV QM QA Qualitätssicherung Qualitymanagement Computerized System Validation CAPA Abweichungen Qmb Changemanagement Change Request Management Good Manufacturing Practice Good Distribution Practice QMS QMB DEVIATION

Produkte / Standards / Erfahrungen / Methoden

Skills

  • GAMP
  • GAMP 5
  • Computer System Validation (CSV)
  • Data Integrity
  • ISO 14971
  • ISO 13485
  • ISO 9001
  • BPMN 2.0
  • ISO 14001
  • ISO 19011
  • GxP
  • SAP
  • ALCOA+
  • Change Management
  • Deviations
  • CAPA


COMPETENCIES

  • Team Work
  • Creativity
  • Communication
  • Self Sufficiency
  • Problem solving


Work Experience

09/2014 - 11/2015

Role: Working Student for Quality Control 

Customer: Kuraray Europe GmbH


Tasks:

Testing according to test instructions, evaluation of data, and documentation

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