Life Science Expert
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- auf Anfrage
- 81829 München
- DACH-Region
- de | en
- 09.06.2026
- Contract ready
Kurzvorstellung
Pharmaceutical Industry since 2008
Freelance since 2012
Geschäftsdaten
Qualifikationen
Projekt‐ & Berufserfahrung
4/2022 – 10/2025
Tätigkeitsbeschreibung
End-to-end MES implementation projects (Körber PAS-X) in GMP-regulated environments
• Responsibility for Computer System Validation (CSV: planning, IQ/OQ/PQ execution &
documentation)
• Creation, review and maintenance of GMP-compliant documentation (URS, specifications,
protocols, reports)
• Development and delivery of system- and process-related trainings (key users, end users)
• Maintenance of training documentation and evidence (training matrices, attendance
records)
• Cross-functional project management (QA, IT, Production) and stakeholder alignment
• Audit and inspection readiness support (documentation packages, evidence provision,
follow-up)
• Continuous improvement initiatives (OPEX)
Audits, Dokumentenmanagement, Manufacturing Execution Systems, Projektmanagement (IT), Prozessvalidierung, Schulungskonzepte
1/2020 – 4/2022
Tätigkeitsbeschreibung
• Process Owner for Change Management (assessment, documentation, implementation
tracking)
• SOP and document lifecycle management (creation, review, approval workflows)
• Batch record review and release support
• Planning and execution of self-inspections; co-auditor activities; follow-up of findings
• Deviation and CAPA management (investigation support, effectiveness checks)
• Risk management (assessments and mitigation plans)
• Training coordination and documentation (training concepts, matrices, evidence)
Schulung / Training (IT), Schulungskonzepte, Dokumentenmanagement, Change Management, Risikomanagement, Auditor
4/2019 – 7/2019
Tätigkeitsbeschreibung
Operational Qualification/ Validation (LabWare7)
- Creation of URS
- Risk analysis
- Creation of Test Reports
- Traceability-Matrix
- System tests (Stability)
- Database Maintenance/ Master Data
- Creation of manuals & training documents
- Creation of requirements specifications
Pharmazie
4/2013 – 4/2019
Tätigkeitsbeschreibung
Implementation of HeLIS/LIMS (LabWare 6&7)
(Cell Culture & Protein Science)
- Creation of manuals/ training documents/ SOP´s
- Preparation and planning of trainings
- Database Maintenance/ Master Data
- Data analysis
- Risk Management
- Performance tests/ System tests
- First Level Support
Pharmazie
1/2013 – 3/2013
Tätigkeitsbeschreibung-/-
Eingesetzte QualifikationenAdministration von Datenbanken
12/2012 – 12/2012
Tätigkeitsbeschreibung-/-
Eingesetzte QualifikationenProjektassistenz
10/2012 – 10/2012
Tätigkeitsbeschreibung-/-
9/2012 – 10/2012
Tätigkeitsbeschreibung-/-
9/2012 – 9/2012
Tätigkeitsbeschreibung./.
5/2012 – 8/2012
Tätigkeitsbeschreibung-/-
5/2012 – 5/2012
Tätigkeitsbeschreibung-/-
11/2011 – 3/2012
Tätigkeitsbeschreibung
Monitoring, CRA
Pharmaceutical drug safety
Regulatory Affairs
Product management/ Marketing
Project management
Distribution/ Sales
11/2009 – 8/2011
Tätigkeitsbeschreibung
-Responsible for study start up activities, including creating site folders, collating, preparing and maintaining SIP documents, updating systems
-Track study related supplies and facilitate their distribution to the site, including preparing and distributing Study File Binders, study drugs and Site Initiation presentations/materials
-Ensures collection, review, track and provision of appropriate clinical documents to support regulatory submissions
-Responsible for the submissions to the Ethics Committee and Federal Office for Radiation Protection
-Tracking and filing of essential documents and submission to the Trial Master File
-Orders, processes and follow-up on query resolution if required
-Organize meetings (Investigator, Study Team)
-Training of new staff
-Coordinate entry and maintenance of local data into study management systems
-Study administrative support and translations
-Support of audits and inspections
-Responsible for local archiving system
-Data Steward & local IB-Coordinator
-Close cooperation with Investigators, Study team, Regulatory
Affairs, Ethics Committee, Safety and Contract Staff
4/2008 – 10/2009
Tätigkeitsbeschreibung
-Assist with special projects and studies
-Enter information and data in MS Office tools and systems tools
-Communicate with international team members and clients
-Assist and guide the team/project members
-Preparing submissions to the EC and local competent Authorities
-Handle administrative work / provide quality administration support to the clients
-Coordinate trainings and meetings
1/2007 – 11/2007
Tätigkeitsbeschreibung
-Leadership as well as responsible for the industrial area and 25 employees
-HR management
-Concept development
-Support of the management
-Contact partner for customers and suppliers
-Staff recruitment, planning and development
-Sales and distribution
-General organization as well as calculation
Dienstleistung (allg.)
7/2006 – 12/2006
Tätigkeitsbeschreibung
-Arrangement / care and allocation of external employees
-Customer care / customer consulting
-Disposal / coordination of external assignments
-Personnel recruitment, administration and mediation
-Customer acquisition and resource planning
Dienstleistung (allg.)
9/2005 – 6/2006
Tätigkeitsbeschreibung
-Administrative and processing tasks in the HR Department
-Order processing/ order management
-Staff management & administration
-Invoicing
-Payroll accounting
-Preparatory bookkeeping
-Cash management
-Purchasing
-Contract management
Dienstleistung (allg.)
1/2003 – offen
Tätigkeitsbeschreibung
• Individualized dog care and handling services with strong focus on behavioral awareness,
safety and responsible supervision
• Development and implementation of a premium small-scale care concept emphasizing
structured routines, balanced exercise and individual needs
• Client relationship management including consultation, service coordination and
scheduling
• Continuous refinement and expansion of the services and specialized care offerings
Geschäftsführer Tierpension, Hundetrainer, Tierschutz
Zertifikate
Ausbildung
Fürstenfeldbruck
Über mich
pharmaceutical and biotech environments, with a strong focus on Quality Management, CSV,
MES/LIMS, documentation, audit readiness and training.
Extensive background in both permanent roles and freelance / project-based assignments,
enabling fast integration into existing organizations and effective collaboration across QA, IT,
Production and Regulatory functions. Proven experience acting as trainer and key user, including
the development, delivery and documentation of GMP-, system- and process-related trainings.
Hands-on experience supporting audits, inspections and self-inspections, from preparation and
documentation to evidence provision and follow-up activities.
In parallel, development of a self-employed premium dog care service (CASADOBI) focused on
individualized animal care, behavioral awareness and structured small-scale care environments.
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Europäische Union
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