Highly skilled and results-driven professional with a strong background in Business Analysis, Computer System Validation and QA in Pharma
Aktualisiert am 28.10.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 02.11.2025
Verfügbar zu: 100%
davon vor Ort: 20%
data integrity
Good Manufacturing Practice
Geschäftsprozessanalyse
BPMN
process mapping
Requirements Engineering
FMEA
Risk Assessment
Computerized System Validation
Qualitymanagement
QMS
Qualitätssicherung
Software Quality Assurance
Quality Control
Dokumentenmanagementsystem
LIMS
MES
SAP QM
Validierung
Qualifizierungsingenieur
Projektmanagement/Projektleitung
Teamleading
Scrum Product Owner
Romanian
Muttersprache
German
C1
English
C1

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

1 year 5 months
2024-06 - now

Digital Transformation process

Business Analyst
Business Analyst
Digital Transformation process: implementation and replacement of regulatory systems (RIM, DMS, submission management systems) Veeva Vault for a renowned generics and biosimilars pharmaceutical company in Tirol
  • Hypercare SPOC (incl. fulfilling ServiceNow requests and incidents)
  • Collaborate with stakeholders to gather business enhancement requirements
  • Assess and prioritize new enhancement requirements
  • Work in an agile framework to support the implementation of enhancements
  • Facilitate quick defect resolution and change requests while in a productive GxP system
  • Training Lead:
    • provide a data governance concept
    • provide a training concept for the various roles and permissions in the system
    • collaborate with internal training admins to create training materials and ensure timely communication to the stakeholders
    • roll-out trainings ensuring compliance with the company?s policy and processes
  • Project handover to internal business teams
  • Provide general support on inquires from end users regarding the application


Implementation of SAP S/4 Hana and EWM for a renowned gene therapy and biopharmaceutical company in Bavaria

  • Worked in a scaled agile framework, being responsible for the collaboration with respective functions from our ART and other affected teams.
  • Assess SAP S/4 Hana (MM, EWM) requirements for Gene Therapy Development Center
  • Assess business needs and requirements for the interface SAP S/4 Hana (MM, EWM) with partner systems (MES, sLIMS)
  • Provide input and collaborate with partners and other Sites about implementing strategies
  • Responsible for the User Access, Roles and Training strategy, ensuring all affected stakeholders get the required access at GoLive, ensuring data integrity and compliance.
  • Hypercare phase SPOC
  • Created the test scripts and overlooked the formal testing activities
  • Material Master Data SPOC

1 year 3 months
2023-04 - 2024-06

Implementation and replacement of regulatory systems

Senior Regulatory and Digital Solutions Manager, Business Analyst/Product Owner
Senior Regulatory and Digital Solutions Manager, Business Analyst/Product Owner
Digital Transformation process: implementation and replacement of regulatory systems (RIM, DMS, submission management systems) Veeva Vault for a renowned generics and biosimilars pharmaceutical company in Tirol
  • Collaborated with stakeholders to understand business requirements and objectives, ensuring alignment with process improvement initiatives
    • Business Process Mapping
    • Gap Analysis
    • Risk Assessment
  • Conducted in-depth process analysis to identify gaps, bottlenecks, and areas for improvement, leveraging industry best practices and regulatory compliance
  • Worked closely with cross-functional teams to gather requirements, define project scope, and establish clear objectives for process improvement initiatives
    • Identification and specification of relevant metadata fields and processes (e.g. registration master data, documents types and subtypes, document metadata fields, templates, overlays).
    • Consulting on the definition of data interfacing and workflow logic.
    • Translate business requirements into implementable technical specifications.
  • Provide input and collaborate with different cross-functional teams about the implementing strategies, ensuring timelines and CSV compliance, as well as Data Integrity
  • Coordination with SMEs from RA, Quality, IT and integration partners (Veeva, Select docubridge, Trackwise, middleware) to define, translate, and prioritize requirements.
  • Worked in an agile framework, being responsible for the creation of user stories, acceptance criteria, process mappings, functional risk assessments, test cases/scripts
  • Overlooked the testing activities and facilitated defect resolution
Teccon Consulting GmbH/Capgemini Engineering Austria (Vienna, Austria)
4 months
2024-01 - 2024-04

Prompt Engineering

Compliance Domain Expert
Compliance Domain Expert

Prompt Engineering, retrieval augmented generation, model fine-tuning for a renowned AI Solutions Enterprise

9 months
2022-07 - 2023-03

various Projects

Senior Quality & Regulatory Compliance Engineer
Senior Quality & Regulatory Compliance Engineer
C&Q Team Lead ? Pandemic preparedness project at a pharmaceutical company in Germany
  • Leading interdisciplinary C&Q-Teams fostering stakeholder engagement, cross-functional collaboration, communication support and risk mitigation tactics
  • Leading and planning of C&Q and CSV projects, ensuring timelines and alignment to the implementation strategies
  • Analyzed and managed anticipated and persistent resistance to change and digitalization
  • Development and creation of GMP-compliant qualification/validation concepts (business analysis)
  • Creation of deliverables: user requirements specifications, validation plan, design qualification, functional risk assessments, IQ/OQ/PQ test plans and test cases, validation report, deviation reports)
  • Consulting on general CSV & Data Integrity topics, promoting continuous improvement in the QA and Quality Management Systems
  • Responsible for the project schedule, reporting and ensure communication to senior management team / project leadership team


CSV & Compliance Consultant ? generics pharmaceutical company in Bulgaria

  • Coached QA Team Leads on general CSV & Data Integrity topics, promoting continuous improvement in the QA and Quality Management Systems
  • Supported team with implementation of CSV and Data Integrity strategies to ensure compliance with EU and FDA regulatory guidelines
  • Ensure preparedness for future GMP manufacturing


Project Engineer ? Risk Mitigation Project: Commissioning, Qualification and Validation of a newly built production area at a renowned Animal Health company in Austria

  • Leading and planning the C&Q and CSV activities (business analysis)
  • Development and creation of GMP-compliant qualification/validation concepts
  • Creation of deliverables: user requirements specifications, functional specifications, VP, DQ, risk assessments, IQ, OQ, PQ, testing, VR, deviation reports)
  • Consulting on CSV & Data Integrity topics
  • Support the team in performing SAT activities for various C&Q utilities and systems

Baker Hicks GmbH (Vienna, Austria)
2 years 4 months
2020-03 - 2022-06

Creation, coordination and monitoring of a project plan

Senior Validation Specialist/Data Integrity Management System Owner
Senior Validation Specialist/Data Integrity Management System Owner
  • Leading a SME team in the fields of CSV&C/Data Integrity (20 pax)
  • Monitoring of the local implementation of global computer systems/ processes (e.g. implementation of SAP S4/HANA, new DMS, new LIMS, new MES, new Trackwise features)
  • Creation, coordination and monitoring of a project plan, risk analysis and action log
  • Improvement, standardization and simplification of processes (Lean Validation)
  • Creation of CSV templates, final QA approval of CSV&Q documentation
  • Performing audits and self-inspections on site to ensure conformity to SOPs and regulatory requirements (ISPE GAMP, FDA 21 CFR Part 11, EU GMP, ICH Q, MHRA)
  • Presentation of relevant topics during external audits and regulatory inspections
  • Creation, assessment and evaluation of deviations, change requests and rationales
  • Creation and monitoring or implementation of CAPAs
  • Maintain Configuration Items in CMDB
Boehringer-Ingelheim RCV (Vienna, Austria)
3 years 4 months
2016-11 - 2020-02

GMP method validations/ transfers

Advanced HPLC-Analyst
Advanced HPLC-Analyst
  • Planning, execution, implementation and documentation of GMP method validations/ transfers and analyses, equipment qualifications and non-GMP studies
  • Creation, assessment and evaluation of deviations, OOX, change requests, CAPAs
  • Contact person for external vendors/CMOs and outsourcing of analyses
  • Performing HPLC, IC and Sequencer GMP and non-GMP analyses
  • Second Person Verification of analytical reports
Boehringer-Ingelheim RCV (Vienna, Austria)

Aus- und Weiterbildung

Aus- und Weiterbildung

10 months
2009-10 - 2010-07

Biochemical Engineering

University Babes-Bolyai, Cluj-Napoca, Romania
University Babes-Bolyai, Cluj-Napoca, Romania

Kompetenzen

Kompetenzen

Top-Skills

data integrity Good Manufacturing Practice Geschäftsprozessanalyse BPMN process mapping Requirements Engineering FMEA Risk Assessment Computerized System Validation Qualitymanagement QMS Qualitätssicherung Software Quality Assurance Quality Control Dokumentenmanagementsystem LIMS MES SAP QM Validierung Qualifizierungsingenieur Projektmanagement/Projektleitung Teamleading Scrum Product Owner

Produkte / Standards / Erfahrungen / Methoden

Personal Skills
  • Excellent leadership and problem-solving skills
  • Excellent stakeholder management skills
  • Aim-oriented, ambitious, curious to learn more
  • Agile and Hands-on mindset, adaptable to changes
  • Organized, structured and pragmatic


Skills and Competences

  • Quality Management Systems 
    • Trackwise, Salesforce, SAP SolMan 7.2, HP ALM
  • Documentation Management Systems 
    • Veeva Vaults, DOORS, Documentum, and others
  • Chromatography Data Systems 
    • Waters Empower 3; Thermo Fisher Chromeleon, Agilent Chemstation
  • LIMS:
    • Labware, LabX (Mettler Toledo)
  • MES:
    • BioMES (Körber Werum) and PharmaSuite (Rockwell)
  • ERP Systems:
    • SAP Insure, S/4HANA, S/4EWM
  • Project Management Tools:
    • MS Teams Whiteboard, Mural, Visio, Power BI, Miro, Lucid
  • Agile Project Management Tools:
    • Monday, Jira
  • BPMN Tool:
    • Adonis
  • Testing Tool:
    • HP ALM
  • Other:
    • ?Microsoft Office 360, G-Suite, Confluence


Work Experience

05/2016 - 10/2016

Role: Tutor 

Customer: Faculty of Chemistry, University of Vienna


Tasks:

biological-chemical and the analytical part of the introductory laboratory practices (supervising 30 students)


05/2015 - 05/2015

Role: Tutor 

Customer: Faculty of Chemistry, University of Vienna


Tasks:

biological-chemical and the analytical part of the introductory laboratory practices (supervising 30 students)


03/2014 - 04/2014

Role: Intern 

Customer: University of Clemson (South Carolina, United States):


Tasks:

Training in concepts of regenerative medicine, associated processes and applications


09/2013 - 02/2014


Tasks:

Initiation and leading a seminar for first semester students (30 students per group)

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

1 year 5 months
2024-06 - now

Digital Transformation process

Business Analyst
Business Analyst
Digital Transformation process: implementation and replacement of regulatory systems (RIM, DMS, submission management systems) Veeva Vault for a renowned generics and biosimilars pharmaceutical company in Tirol
  • Hypercare SPOC (incl. fulfilling ServiceNow requests and incidents)
  • Collaborate with stakeholders to gather business enhancement requirements
  • Assess and prioritize new enhancement requirements
  • Work in an agile framework to support the implementation of enhancements
  • Facilitate quick defect resolution and change requests while in a productive GxP system
  • Training Lead:
    • provide a data governance concept
    • provide a training concept for the various roles and permissions in the system
    • collaborate with internal training admins to create training materials and ensure timely communication to the stakeholders
    • roll-out trainings ensuring compliance with the company?s policy and processes
  • Project handover to internal business teams
  • Provide general support on inquires from end users regarding the application


Implementation of SAP S/4 Hana and EWM for a renowned gene therapy and biopharmaceutical company in Bavaria

  • Worked in a scaled agile framework, being responsible for the collaboration with respective functions from our ART and other affected teams.
  • Assess SAP S/4 Hana (MM, EWM) requirements for Gene Therapy Development Center
  • Assess business needs and requirements for the interface SAP S/4 Hana (MM, EWM) with partner systems (MES, sLIMS)
  • Provide input and collaborate with partners and other Sites about implementing strategies
  • Responsible for the User Access, Roles and Training strategy, ensuring all affected stakeholders get the required access at GoLive, ensuring data integrity and compliance.
  • Hypercare phase SPOC
  • Created the test scripts and overlooked the formal testing activities
  • Material Master Data SPOC

1 year 3 months
2023-04 - 2024-06

Implementation and replacement of regulatory systems

Senior Regulatory and Digital Solutions Manager, Business Analyst/Product Owner
Senior Regulatory and Digital Solutions Manager, Business Analyst/Product Owner
Digital Transformation process: implementation and replacement of regulatory systems (RIM, DMS, submission management systems) Veeva Vault for a renowned generics and biosimilars pharmaceutical company in Tirol
  • Collaborated with stakeholders to understand business requirements and objectives, ensuring alignment with process improvement initiatives
    • Business Process Mapping
    • Gap Analysis
    • Risk Assessment
  • Conducted in-depth process analysis to identify gaps, bottlenecks, and areas for improvement, leveraging industry best practices and regulatory compliance
  • Worked closely with cross-functional teams to gather requirements, define project scope, and establish clear objectives for process improvement initiatives
    • Identification and specification of relevant metadata fields and processes (e.g. registration master data, documents types and subtypes, document metadata fields, templates, overlays).
    • Consulting on the definition of data interfacing and workflow logic.
    • Translate business requirements into implementable technical specifications.
  • Provide input and collaborate with different cross-functional teams about the implementing strategies, ensuring timelines and CSV compliance, as well as Data Integrity
  • Coordination with SMEs from RA, Quality, IT and integration partners (Veeva, Select docubridge, Trackwise, middleware) to define, translate, and prioritize requirements.
  • Worked in an agile framework, being responsible for the creation of user stories, acceptance criteria, process mappings, functional risk assessments, test cases/scripts
  • Overlooked the testing activities and facilitated defect resolution
Teccon Consulting GmbH/Capgemini Engineering Austria (Vienna, Austria)
4 months
2024-01 - 2024-04

Prompt Engineering

Compliance Domain Expert
Compliance Domain Expert

Prompt Engineering, retrieval augmented generation, model fine-tuning for a renowned AI Solutions Enterprise

9 months
2022-07 - 2023-03

various Projects

Senior Quality & Regulatory Compliance Engineer
Senior Quality & Regulatory Compliance Engineer
C&Q Team Lead ? Pandemic preparedness project at a pharmaceutical company in Germany
  • Leading interdisciplinary C&Q-Teams fostering stakeholder engagement, cross-functional collaboration, communication support and risk mitigation tactics
  • Leading and planning of C&Q and CSV projects, ensuring timelines and alignment to the implementation strategies
  • Analyzed and managed anticipated and persistent resistance to change and digitalization
  • Development and creation of GMP-compliant qualification/validation concepts (business analysis)
  • Creation of deliverables: user requirements specifications, validation plan, design qualification, functional risk assessments, IQ/OQ/PQ test plans and test cases, validation report, deviation reports)
  • Consulting on general CSV & Data Integrity topics, promoting continuous improvement in the QA and Quality Management Systems
  • Responsible for the project schedule, reporting and ensure communication to senior management team / project leadership team


CSV & Compliance Consultant ? generics pharmaceutical company in Bulgaria

  • Coached QA Team Leads on general CSV & Data Integrity topics, promoting continuous improvement in the QA and Quality Management Systems
  • Supported team with implementation of CSV and Data Integrity strategies to ensure compliance with EU and FDA regulatory guidelines
  • Ensure preparedness for future GMP manufacturing


Project Engineer ? Risk Mitigation Project: Commissioning, Qualification and Validation of a newly built production area at a renowned Animal Health company in Austria

  • Leading and planning the C&Q and CSV activities (business analysis)
  • Development and creation of GMP-compliant qualification/validation concepts
  • Creation of deliverables: user requirements specifications, functional specifications, VP, DQ, risk assessments, IQ, OQ, PQ, testing, VR, deviation reports)
  • Consulting on CSV & Data Integrity topics
  • Support the team in performing SAT activities for various C&Q utilities and systems

Baker Hicks GmbH (Vienna, Austria)
2 years 4 months
2020-03 - 2022-06

Creation, coordination and monitoring of a project plan

Senior Validation Specialist/Data Integrity Management System Owner
Senior Validation Specialist/Data Integrity Management System Owner
  • Leading a SME team in the fields of CSV&C/Data Integrity (20 pax)
  • Monitoring of the local implementation of global computer systems/ processes (e.g. implementation of SAP S4/HANA, new DMS, new LIMS, new MES, new Trackwise features)
  • Creation, coordination and monitoring of a project plan, risk analysis and action log
  • Improvement, standardization and simplification of processes (Lean Validation)
  • Creation of CSV templates, final QA approval of CSV&Q documentation
  • Performing audits and self-inspections on site to ensure conformity to SOPs and regulatory requirements (ISPE GAMP, FDA 21 CFR Part 11, EU GMP, ICH Q, MHRA)
  • Presentation of relevant topics during external audits and regulatory inspections
  • Creation, assessment and evaluation of deviations, change requests and rationales
  • Creation and monitoring or implementation of CAPAs
  • Maintain Configuration Items in CMDB
Boehringer-Ingelheim RCV (Vienna, Austria)
3 years 4 months
2016-11 - 2020-02

GMP method validations/ transfers

Advanced HPLC-Analyst
Advanced HPLC-Analyst
  • Planning, execution, implementation and documentation of GMP method validations/ transfers and analyses, equipment qualifications and non-GMP studies
  • Creation, assessment and evaluation of deviations, OOX, change requests, CAPAs
  • Contact person for external vendors/CMOs and outsourcing of analyses
  • Performing HPLC, IC and Sequencer GMP and non-GMP analyses
  • Second Person Verification of analytical reports
Boehringer-Ingelheim RCV (Vienna, Austria)

Aus- und Weiterbildung

Aus- und Weiterbildung

10 months
2009-10 - 2010-07

Biochemical Engineering

University Babes-Bolyai, Cluj-Napoca, Romania
University Babes-Bolyai, Cluj-Napoca, Romania

Kompetenzen

Kompetenzen

Top-Skills

data integrity Good Manufacturing Practice Geschäftsprozessanalyse BPMN process mapping Requirements Engineering FMEA Risk Assessment Computerized System Validation Qualitymanagement QMS Qualitätssicherung Software Quality Assurance Quality Control Dokumentenmanagementsystem LIMS MES SAP QM Validierung Qualifizierungsingenieur Projektmanagement/Projektleitung Teamleading Scrum Product Owner

Produkte / Standards / Erfahrungen / Methoden

Personal Skills
  • Excellent leadership and problem-solving skills
  • Excellent stakeholder management skills
  • Aim-oriented, ambitious, curious to learn more
  • Agile and Hands-on mindset, adaptable to changes
  • Organized, structured and pragmatic


Skills and Competences

  • Quality Management Systems 
    • Trackwise, Salesforce, SAP SolMan 7.2, HP ALM
  • Documentation Management Systems 
    • Veeva Vaults, DOORS, Documentum, and others
  • Chromatography Data Systems 
    • Waters Empower 3; Thermo Fisher Chromeleon, Agilent Chemstation
  • LIMS:
    • Labware, LabX (Mettler Toledo)
  • MES:
    • BioMES (Körber Werum) and PharmaSuite (Rockwell)
  • ERP Systems:
    • SAP Insure, S/4HANA, S/4EWM
  • Project Management Tools:
    • MS Teams Whiteboard, Mural, Visio, Power BI, Miro, Lucid
  • Agile Project Management Tools:
    • Monday, Jira
  • BPMN Tool:
    • Adonis
  • Testing Tool:
    • HP ALM
  • Other:
    • ?Microsoft Office 360, G-Suite, Confluence


Work Experience

05/2016 - 10/2016

Role: Tutor 

Customer: Faculty of Chemistry, University of Vienna


Tasks:

biological-chemical and the analytical part of the introductory laboratory practices (supervising 30 students)


05/2015 - 05/2015

Role: Tutor 

Customer: Faculty of Chemistry, University of Vienna


Tasks:

biological-chemical and the analytical part of the introductory laboratory practices (supervising 30 students)


03/2014 - 04/2014

Role: Intern 

Customer: University of Clemson (South Carolina, United States):


Tasks:

Training in concepts of regenerative medicine, associated processes and applications


09/2013 - 02/2014


Tasks:

Initiation and leading a seminar for first semester students (30 students per group)

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