Nicole LUXENBURGER
Referent Validierung
Heining les Bouzonville,Grand Est
Summary
Proficient in conducting risk assessment and root cause analysis to identify and mitigate quality issues. Adept at identifying and resolving compliance issues efficiently and effectively. Committed to continuous improvement and upholding product integrity.
Expertise in identifying the root cause of quality issues and implementing corrective actions to mitigate risks. Adept in using data analysis and statistical process control to enhance quality.
Overview
15
15
years of professional experience
3
3
Languages
Work History
Referent Validation
URSAPHARM Arzneimittel GmbH
Saarbrücken
04.2021 - Current
- Executing and supporting qualification (FAT, SAT, IQ, OQ and PQ)
- Writing validation-related documents, including: Related Risk assessment Tasks
- Executing and supporting validation activities (e.g. cleaning validation and sterilisation)
- Management of deviations and CAPA related to validation activities
- Providing technical input and support for SOPs
- Tools and methodologies: TrackWise, SAP, FTA, FMEA, CIP, CAPA and change control
GMP-Agent
SW Pharma GmbH
Schiffweiler
10.2016 - 03.2021
- Writing and updating manufacturing instructions and SOPs
- Implementing and supporting validation activities and related risk assessment tasks
- Qualification and calibration of equipment
- Training employees
- Safeguarding compliance with the GMP system
- Deviation management related to validation activities
- Tools and methodologies: FMEA, CAPA and change control
Employee Quality Management
SW Pharma GmbH
Schiffweiler
04.2012 - 09.2016
- Writing and updating quality documents
- Writing documents concerning the qualification of equipment
- Creating PQRs
- Maintaining CAPA systems
- Supporting quality risk management
- Tools and methodologies: CAPA, change control, PQRs
Employee Quality Management
Amapharm GmbH
Merchweiler
07.2010 - 03.2012
- Writing and updating quality documents
- OOS, deviation and complaint management
- Training employees
- Support with supplier audits
- Executing tests on starting materials and bulk
Education
Master - Quality Management
University of Wismar
Germany04.2021
Diploma Degree - Ecorophrology (FH) With Economic Focus
University of Applied Science in Fulda
Germany01.2010
Skills
Applications & Tools: SOP Guard, TrackWise, SAP, MS Office
- Methodologies: DQ, IQ, OQ, PQ, validation plan/ protocol/ report, risk assessment, change control, FMEA, CAPA
- Standards: GMP, ISO 9000 ff, ISO 14001
Training
- Process validation at Concept Heidelberg 01/2021
- CSV at Qfinity 01/2019
KNOWLEDGE DOMAINS OR AREAS
- Validation and qualification
- Quality management
- Complaint management
- Risk management
- Target group specific staff training
Timeline
Referent Validation
URSAPHARM Arzneimittel GmbH
04.2021 - Current
GMP-Agent
SW Pharma GmbH
10.2016 - 03.2021
Employee Quality Management
SW Pharma GmbH
04.2012 - 09.2016
Employee Quality Management
Amapharm GmbH
07.2010 - 03.2012
Master - Quality Management
University of Wismar
Diploma Degree - Ecorophrology (FH) With Economic Focus
University of Applied Science in Fulda
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