Business Quality Representative | SAP Implementation for R&D
Schlagwörter
Skills
CSV, Quality Management, Validation Expert, Data Integrity Expert, Project Managment
Projekthistorie
09/2021
-
12/2022
07/2021
-
12/2022
CSV Strategy | GxP Application Management Consultant for QA & QC
01/2020
-
12/2022
Quality and Compliance Consultant for CSV
01/2020
-
04/2021
Quality and Compliance Consultant
Tuttlingen (DE) CSV Strategy; Karl Storz
* Lead, participation & execution of Quality Management/
CSV-projects within the Global Operations
* Conduct Audit and Inspection Readiness for MDR,
MSDAP and ISO in the area of Computer System
Validation
* Giving Strategy and Advice to establish and improve a
Corporate Framework within existing QMS 13485 for
Computer System Validation, implementing a corporate
procedure for CSV including templates for validation
management
* Implementing CSV Strategy into ITIL processes within IT
& QM Department
* Concepting of Validation Strategy for the Re-validation of
current IT Systems as part of the QMS, full-filling
requirements from FDA (820.20, Part 11), Annex 11 and
ISO 13485, execution of all validation activities and
documentation
* Develop Validation Lifecycle Documentation and
Templates, i.e. Validation Plan, Test Plan, Validation
Report (German and English documentation)
* Change Management
* Supplier Qualification Management
* Preparation & performance of internal, external & third
Party Audits for Supplier Qualification
CSV-projects within the Global Operations
* Conduct Audit and Inspection Readiness for MDR,
MSDAP and ISO in the area of Computer System
Validation
* Giving Strategy and Advice to establish and improve a
Corporate Framework within existing QMS 13485 for
Computer System Validation, implementing a corporate
procedure for CSV including templates for validation
management
* Implementing CSV Strategy into ITIL processes within IT
& QM Department
* Concepting of Validation Strategy for the Re-validation of
current IT Systems as part of the QMS, full-filling
requirements from FDA (820.20, Part 11), Annex 11 and
ISO 13485, execution of all validation activities and
documentation
* Develop Validation Lifecycle Documentation and
Templates, i.e. Validation Plan, Test Plan, Validation
Report (German and English documentation)
* Change Management
* Supplier Qualification Management
* Preparation & performance of internal, external & third
Party Audits for Supplier Qualification
01/2019
-
04/2021
Pharmacist | Senior Quality & Compliance Consultant
Basel (CH); Digital Chameleon GmbH
Digital Chameleon GmbH
* Buisness Development
* Product/ Service Development
* Key Account Management for Pharma or Medical Device
Companies - Project Recruiting / Sales
* Project Management
* CSV Project Consultant
* Data Integrity Expert
* Validation Manager
* Change Management
* Buisness Development
* Product/ Service Development
* Key Account Management for Pharma or Medical Device
Companies - Project Recruiting / Sales
* Project Management
* CSV Project Consultant
* Data Integrity Expert
* Validation Manager
* Change Management
09/2020
-
12/2020
Laboratory Process and Qualification Consultant
Basel (CH); Lonza
* Service Delivery and direct report to head of Quality
Assurance and Laborites
* Change Management
* Support the Project for the Preparation and Execution of
the FDA Pre-Approval Inspections for Commercial
Manufacturing (DS & DP for Molecules, Antibodies)
* Evaluate and mitigate gaps for compliance of FDA PAI
objectives for the new Quality System for Com-metrical
Manufacturing, for example Biological License
Application, Data Integrity, Computer System Validation
* Conceptual improvement, optimization und
harmonization of GxP- and quality relevant process
procedures for pharmaceutical products in quality
projects
* Laboratory Process Qualification for an innovative
approach to improve an electronic Batch release.
Assurance and Laborites
* Change Management
* Support the Project for the Preparation and Execution of
the FDA Pre-Approval Inspections for Commercial
Manufacturing (DS & DP for Molecules, Antibodies)
* Evaluate and mitigate gaps for compliance of FDA PAI
objectives for the new Quality System for Com-metrical
Manufacturing, for example Biological License
Application, Data Integrity, Computer System Validation
* Conceptual improvement, optimization und
harmonization of GxP- and quality relevant process
procedures for pharmaceutical products in quality
projects
* Laboratory Process Qualification for an innovative
approach to improve an electronic Batch release.
08/2020
-
12/2020
Quality Management Consultant DACH
ALK Abello
* Lead, participation & execution of Quality
Management/GMP-projects within the Global Operations
* Data Security/ Protection Management DACH Region
(DSGVO)
* Conceptual improvement, optimization und
harmonization of GxP- and quality relevant process
procedures for pharmaceutical products in quality
projects
* Elaboration of Quality Management documents
Preparation & performance of internal & external GxPaudits
Assistance in preparation of inspections by
competent authorities
* Planning and execution of trainings regarding guidelines
(GMP, ICH, ISO-certification, GDP) and national as well as
international regulations
* Document Management
* Recall Management & Complaint Management
* Ensure that Deviation Investigations and Corrective
Action/Preventive Action (CAPA- Management) plans are
implemented to resolve these risks
* Construction, expansion and implementation of a Quality
Management (DIN ISO 9001 & ISO 13485)
* Data Integrity (ALCOA, GAMP5, FDA, GMP)
* IT Security
* Change Management
* Computer System Validation (CSV) for SAP MM
Management/GMP-projects within the Global Operations
* Data Security/ Protection Management DACH Region
(DSGVO)
* Conceptual improvement, optimization und
harmonization of GxP- and quality relevant process
procedures for pharmaceutical products in quality
projects
* Elaboration of Quality Management documents
Preparation & performance of internal & external GxPaudits
Assistance in preparation of inspections by
competent authorities
* Planning and execution of trainings regarding guidelines
(GMP, ICH, ISO-certification, GDP) and national as well as
international regulations
* Document Management
* Recall Management & Complaint Management
* Ensure that Deviation Investigations and Corrective
Action/Preventive Action (CAPA- Management) plans are
implemented to resolve these risks
* Construction, expansion and implementation of a Quality
Management (DIN ISO 9001 & ISO 13485)
* Data Integrity (ALCOA, GAMP5, FDA, GMP)
* IT Security
* Change Management
* Computer System Validation (CSV) for SAP MM
04/2019
-
07/2019
Quality and Qualification Consultant
Eysins, (CH); Fresenius Kabi Swiss Biosim
* Realization and Implementation of Validation strategy
for local and global Document IT Management Systems
and Laboratory Computer Systems (LIMS, eLMS).
Providing strategy and advice to establish a Corporate
Framework for Project Governance of Computer System
Validation and Equipment Qualification during
Laboratory Relocation (incl:GAMP5).
* GxP Compliance Analysis and Risk Assessment
(FDA,WHO, ICH)
* Creation and Coordination Testing (IQ, OQ, PQ)
* Development and creation of a Traceability Matrix
* Change Management
* Data Integrity (ALCOA, GAMP5, FDA, GMP)
for local and global Document IT Management Systems
and Laboratory Computer Systems (LIMS, eLMS).
Providing strategy and advice to establish a Corporate
Framework for Project Governance of Computer System
Validation and Equipment Qualification during
Laboratory Relocation (incl:GAMP5).
* GxP Compliance Analysis and Risk Assessment
(FDA,WHO, ICH)
* Creation and Coordination Testing (IQ, OQ, PQ)
* Development and creation of a Traceability Matrix
* Change Management
* Data Integrity (ALCOA, GAMP5, FDA, GMP)
02/2019
-
07/2019
Quality and Qualification Consultant
Fresenius Kabi Swiss Biosim
* Laboratory Re-Localization
* Creation and Realization Critical Assessment for
Laboratory Equipment (GxP- Criticality Assessment)
* Analysis of the Laboratory Equipment
* Qualification of Laboratory Equipment (FDA, WHO; GMP)
* Requirements Engineering for a new Work and
Department Environment (GxP)
* Data Flow Process Analysis
* Visualization and perform a Data Flow Process Map for
all Business Process and Laboratory Infrastructure
(VISO, Miro)
* Laboratory Process Gap Analysis
* Change Management
* Data Integrity for Laboratory (ALCOA, GAMP5, FDA, GMP)
* Creation and Realization Critical Assessment for
Laboratory Equipment (GxP- Criticality Assessment)
* Analysis of the Laboratory Equipment
* Qualification of Laboratory Equipment (FDA, WHO; GMP)
* Requirements Engineering for a new Work and
Department Environment (GxP)
* Data Flow Process Analysis
* Visualization and perform a Data Flow Process Map for
all Business Process and Laboratory Infrastructure
(VISO, Miro)
* Laboratory Process Gap Analysis
* Change Management
* Data Integrity for Laboratory (ALCOA, GAMP5, FDA, GMP)
09/2018
-
03/2019
Product Owner
Fresenius Kabi Digital Lab GmbH
* Development of a Software as Medical Devices class IIb
* Product development und optimization
* Software and Hardware-Testing (IEC 62304, IEC 62366)
* Change Control Documentation
* Development and creation of "Nullserien"
* Requirement Engineering for a Software as Medical
Devices class IIb
* Analysis and review of medical Guidelines to implement
Decision Trees and code it into the software
* Preparation and Review Medical and Legal Reviews
* Development and creation of concepts for Data Privacy,
Security and Integrity
* Risk assessment (ISO 14971)
* Requirement Engineer
* Data Protection/ Security
* Change Management
* IT Security
* Product development und optimization
* Software and Hardware-Testing (IEC 62304, IEC 62366)
* Change Control Documentation
* Development and creation of "Nullserien"
* Requirement Engineering for a Software as Medical
Devices class IIb
* Analysis and review of medical Guidelines to implement
Decision Trees and code it into the software
* Preparation and Review Medical and Legal Reviews
* Development and creation of concepts for Data Privacy,
Security and Integrity
* Risk assessment (ISO 14971)
* Requirement Engineer
* Data Protection/ Security
* Change Management
* IT Security
01/2018
-
06/2018
Pharmacist
Baunatal (DE); Neue Apotheke
* Ensure the implementation of regulatory Specification
(AM-HandelsV, GDP-Leitlinie etc.)
* Preparation of intern Inspection and accompaniment of
Inspection of the supervisory authority - Creation and
implementation of concepts for Work safety
* Quality Management
* Quality Assurance of pharmaceutical Products
* Evaluation of the results of investigated Prescription
Medicinal Products Concerning the Active ingredient
concentration, galenic quality (e.g. Particle size,
appearance, etc.), chemical-physical requirement (e.g. ph
value, density, stability, etc.)
* Seminars, e.g. on the topic «Qualitätssicherung in der
Apotheke hergestellter Rezepturen»
* Creation of customer-specific recipes according to the
regulatory requirements (NRF, DAC, EUAB)
(AM-HandelsV, GDP-Leitlinie etc.)
* Preparation of intern Inspection and accompaniment of
Inspection of the supervisory authority - Creation and
implementation of concepts for Work safety
* Quality Management
* Quality Assurance of pharmaceutical Products
* Evaluation of the results of investigated Prescription
Medicinal Products Concerning the Active ingredient
concentration, galenic quality (e.g. Particle size,
appearance, etc.), chemical-physical requirement (e.g. ph
value, density, stability, etc.)
* Seminars, e.g. on the topic «Qualitätssicherung in der
Apotheke hergestellter Rezepturen»
* Creation of customer-specific recipes according to the
regulatory requirements (NRF, DAC, EUAB)
03/2011
-
04/2016
Regional Sales Manager
GUESS INC.
* Evaluation and tabular representation of the sales results
- Customer consultation and acquisition
* Creating offers and internal campaign concepts - Project
Management
* Market observation and analysis
* Purchase Transaction
- Customer consultation and acquisition
* Creating offers and internal campaign concepts - Project
Management
* Market observation and analysis
* Purchase Transaction
06/2011
-
04/2012
Sales Associate
GUESS INC.
* Customer consultation and acquisition
* Creating offers and campaign concepts
* Market observation and analysis
* Evaluation and tabular representation of the sales results
* Creating offers and campaign concepts
* Market observation and analysis
* Evaluation and tabular representation of the sales results
Reisebereitschaft
In der Stadt Hattersheim mit einem Radius von 100 km verfügbar
