Quality Management in Pharma & MedTech/ GMP/ Quality/ Digitization/ Qualified Person (Austria)/ Project & Interim Management
Aktualisiert am 13.05.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 18.04.2024
Verfügbar zu: 100%
davon vor Ort: 80%
GMP
Quality Management
Goal Directed Project Management
Computer-Aided Quality Management
Quality Control
Quality Assurance
Qualified Person
Project Management
PMP
Quality Engineering
Processautomation
Process Management
Lean Six Sigma
Continuous Improvement
CAPA Management
Audit Management
Change Control
Digital Transformation
Consulting
German
mother tongue
English
fluent
French
high school skills
Spanish
basic skills

Einsatzorte

Einsatzorte

München (+300km)
möglich

Projekte

Projekte

1 Monat
2024-04 - heute

Operational Excellence Consultant

Lean Management

Supporting a Medical Diagnostic Labs company in a Lean transformation program

Supporting the Lean Analysis Phase 

Driving local initiatives

Lean Management
amedes
Wasserburg (Bodensee)
6 Monate
2023-08 - 2024-01

Interim Head of Quality Control

Interim Head of Quality Control Quality Control Qualitymanagement Mitarbeiterführung ...
Interim Head of Quality Control

Interim Head of Quality Control acc. to AMG/AMWHV §12

Interim Management of QC Lab (30 FTE)

Interim Management of Analytical Development (5 FTE)

Start-up and Leadership of OOS Improvement Initiative

Pharma
Quality Control Qualitymanagement Mitarbeiterführung Interim Management
Advance Pharma
Berlin
2 Monate
2023-04 - 2023-05

Interim Project Lead QC Readiness

Interim Project Lead QC Readiness Quality Control Projektmanagement
Interim Project Lead QC Readiness

Support QC Readiness workstream in commercial readiness program (for uplift of GMP compliance, qualification of new QC lab, Anal. Method Transfer & Validation, QC Planning and scheduling system).

Biopharma
Quality Control Projektmanagement
Heidelberg (Germany)
3 Monate
2023-01 - 2023-03

PMO for Global QC team / Biopharma

PMO for Global QC team PMO Support Quality Control Good Manufacturing Practice
PMO for Global QC team
  • Act as Global QC PMO to support client Global QC organization in managing relevant portfolio of projects and initiatives
  • Define deliverables, participation to meetings with client Global QC staff and other functions, roadmap/ implementation plan definition, dashboarding/ periodic reporting on progress and completion of defined deliverables, identification and communication of issues and roadblocks to client Global QC and QA
  • Establish team progress monitoring & reporting governance
Vaccines Biopharma
PMO Support Quality Control Good Manufacturing Practice
Remote
11 Monate
2022-02 - 2022-12

QA Consultant / Project Manager

QA Consultant GMP Projektmanagement Pharma ...
QA Consultant
  • Project Lead for implementation of eQMS (MasterControl) and harmonization of QMS for Actylis EU (5 sites)
  • Creation of harmonized SOP?s for QMS
  • Trainer & System Administrator for MasterControl Go-live
  • Market release of Nutraceuticals, Fine Chemicals and API?s
MasterControl Pharma
GMP Projektmanagement Pharma Master Control QMS
Actylis (ex Aceto)
Remote
4 Monate
2021-09 - 2021-12

Head of Quality Unit / Pharma CMO

Head of Quality Unit CMOS Qualitymanagement Mitarbeiterführung
Head of Quality Unit
  • Responsible for Site Quality Unit (50+ FTE in QA & QC)
  • Ad-interim Head of QA (vacant position)
  • Ongoing Site Quality Remediation Management
  • Ongoing Quality Agreement Remediation Project 
  • Initiation and hands-on management of Overdue CAPA Remediation Project
  • Budgeting for Quality Unit
  • Lean QC efficiency project start-up, establishment of production planning-based forecast tool for QC workload
  • Staffing of vacant QA department roles and transition planning for key roles due to ongoing QA reorganization
  • Quality KPI reporting for local and global organization
  • Conduct of Quality Board and follow-up on action items
  • Assessment of compliance gaps and uplift of GMP level 
Pharma
CMOS Qualitymanagement Mitarbeiterführung
Swiss Caps GmbH/ Aenova Group, Bad Aibling (Germany)
Bad Aibling (Germany)
2 Jahre 8 Monate
2019-01 - 2021-08

Technology Consulting Principal

Technology Consulting Principal MES Design Control Projektmanagement ...
Technology Consulting Principal

2021-04 - 2021-07

  • Project Manager for biopharmaceutical manufacturing IT/OT assessment project, Global Biopharma client 


2021-02 - 2021-04

  • Subject Matter Expert for pharmaceutical manufacturing in Project ?Digital Performance Boards? ? Design and digital roadmap for a Continuous Manufacturing Digital Dashboard; Global Pharma client 


2019-10 -2019-12

  • Consulting services: Establishment of a Global MES System Technical Change Management process & SOP; Global Biopharma Client 


2020-07 - 2020-07

  • Subject Matter Expert for pharmaceutical quality business processes (QA, QC, QMS) in internal Project ?Digital Greenfield Reference Plant? 


2020-06 - 2020-06

  • Sub-Project Manager for workstreams Design Transfer, Design Changes, Service Tools in a complex, international MedTech R&D Project; Global MedTech Client


2019-02 - 2019-04

  • Consulting services: Ad-interim Project Governance for a Global MES Implementation Project in a pharma manufacturing plant in China (remote); Global Biopharma Client
  • Business development, sales support and solution selling

Werum IT Solutions Medizinprodukte Pharma
MES Design Control Projektmanagement Beratung
Accenture GmbH, Office Munich (Germany)
Germany
2 Jahre 5 Monate
2016-08 - 2018-12

Senior Consultant - Quality Consulting Services for Life Sciences Clients

Senior Consultant - Life Sciences Qualitätsengineering Qualitätsprüfung Beratung ...
Senior Consultant - Life Sciences
2018-09 - 2018-12

  • Consulting services: Senior Quality Systems Engineer ? Overdue CAPA & Audit Observation Remediation for Global MedTech Client


2016-09 - 2018-09

  • Quality Systems Engineer for DePuy Synthes, Plant Salzburg, Austria, labor leasing contract


2016-08 - 2019-09

  • Consulting service for Utilities Qualification Project; Global  Biopharma Client

  • Sales support in business closing and solution selling
  • German coordinator for Altran-internal international knowledge sharing transfer program (PULSE)
  • SPOC for Biopharmaceutical Industry client (interviewing, staffing and placement of consultants)

Medizinprodukte
Qualitätsengineering Qualitätsprüfung Beratung Performance Qualification CAPA
Altran S.A.S. & Co. KG, Munich, Germany
Salzburg, Wien, Tuttlingen, München
2 Jahre
2016-09 - 2018-08

Quality System Engineer / Medical Devices

Quality System Engineer DIN 13485 Qualitymanagement Quality Control ...
Quality System Engineer
  • Responsible for local QMS system implementation, maintenance, and continuous improvement; coordination of Quality Team Inspection and Test (4 FTE); audit readiness and audit observation / CAPA coordination; investigation and escalation of quality issues
Medizinprodukte
DIN 13485 Qualitymanagement Quality Control Audit
DePuy Synthes Österreich GmbH, Salzburg, Austria
Salzburg, Austria
4 Jahre 4 Monate
2012-04 - 2016-07

Project Management Operational Excellence / Pharma

Project Manager Operational Excellence Projektmanagement Lean Management Operational Excellence ...
Project Manager Operational Excellence
2013-01 - 2016-07

  • Project Manager for MES EBR Rollout Project: Deployment of WERUM PAS-X MES system for approx. 900 TechOps end users: leading a cross-functional project team of 2-10 FTE; managing 2,4 Mio? budget; implementing required hardware, software changes, end-user training & buy-in for electronic batch recording (paper-on-glass approach) in pharma manufacturing


2012-04 - 2013-01

  • Project Manager for TechOps Lean Transformation Project in Sterile FDF Production as follow-up of a McKinsey study: Leading a cross-functional project team of approx
  • 5 FTE for evaluation and implementation of various LEAN tools, methods and processes on the shopfloor, employee mindset change and buy-in for LEAN principles
  • Lean Six Sigma Program initiation and deployment in TechOps
  • Employee suggestion system coordinator for TechOps

Pharma Werum IT Solutions
Projektmanagement Lean Management Operational Excellence MES Programmmanagement Kontinuierlicher Verbesserungsprozess
TechOps, Sandoz GmbH, Kundl (Austria)
Kundl (Austria)
1 Jahr 5 Monate
2010-11 - 2012-03

Head Global Process Management

Head Global Process Management Kontinuierlicher Verbesserungsprozess Lean Management Projektmanagement ...
Head Global Process Management
  • Providing technical support, monitoring performance, and driving continuous improvement initiatives and projects for Sandoz Global Manufacturing Network Anti-Infectives (7 European sites, 1 Asian site)
  • Change Agent for Global Lean Six Sigma Program deployment in Sandoz Business Unit Anti-Infectives 
  • Project Manager for ?Theoretical Limit in Energy Management? pilot project at Sandoz Site Frankfurt 01-03/2012: hands-on feasibility study of McKinsey methodology, identification, and evaluation of yet unknown levers for energy savings (approx. 500 k? p.a. potential identified with payback < 2 years)
Pharma Active Pharmaceutical Ingredients
Kontinuierlicher Verbesserungsprozess Lean Management Projektmanagement Stakeholdermanagement Operational Excellence
Sandoz GmbH, Kundl (Austria)
2 Jahre 9 Monate
2008-02 - 2010-10

Head of IPC/QC Analytical & Technical Process Support Labs

Head IPC/QC Analytical & Technical Process Support Laboratory Good Manufacturing Practice Quality Control Mitarbeiterführung ...
Head IPC/QC Analytical & Technical Process Support Laboratory
  • People lead of 12 lab associates in a QC laboratory
  • Technical process improvement & troubleshooting of API manufacturing processes
  • Analytics, QC, IPC of raw materials, intermediates, API's and FDF's
  • analytical methods including e.g. pharmaceutical water analysis, HPLC, GC, GPC, UV/VIS, enzymatic methods, physical characteristics, electrophoresis
Active Pharmaceutical Ingredients Pharma
Good Manufacturing Practice Quality Control Mitarbeiterführung Prozessentwicklung
Sandoz GmbH, Schaftenau (Austria)
Schaftenau (Austria)
5 Jahre 1 Monat
2003-01 - 2008-01

Head of IPC/QC Analytical Laboratory

Head IPC/QC Analytical Laboratory Good Manufacturing Practice Quality Control Mitarbeiterführung
Head IPC/QC Analytical Laboratory
  • People lead of 8 lab associates in a QC laboratory
  • Uplift of GMP level to ongoing inspection readiness
  • Analytics, QC, IPC of raw materials, intermediates, API's
  • analytical methods including e.g. pharmaceutical water analysis, HPLC, GC, UV/VIS, enzymatic methods, physical characteristics
  • Information security coordinator; SAP business super user
Pharma
Good Manufacturing Practice Quality Control Mitarbeiterführung
Sandoz GmbH, Schaftenau (Austria)

Aus- und Weiterbildung

Aus- und Weiterbildung

2 Jahre 4 Monate
2022-03 - 2024-06

MasterControl SysAdmin

Hybrid online training, MasterControl
Hybrid online training, MasterControl
2 Monate
2024-01 - 2024-02

open HPI Winterschool (AI & Maschinelles Lernen)

openHPI
openHPI

Künstliche Intelligenz und Maschinelles Lernen für Einsteiger

Künstliche Intelligenz und Maschinelles Lernen in der Praxis

ChatGPT: Was bedeutet generative KI für unsere Gesellschaft?

KI und Datenqualität - Perspektiven aus Data Science, Ethik, Normung und Recht

3 Monate
2023-06 - 2023-08

Lead Auditor ISO 13485 & ISO 17025

Lead Auditor ISO 13485 & ISO 17025, Exemplar Global
Lead Auditor ISO 13485 & ISO 17025
Exemplar Global
1 Jahr
2022-01 - 2022-12

Manager Regulatory Affairs

Manager Regulatory Affairs, TH / Uni Lübeck
Manager Regulatory Affairs
TH / Uni Lübeck

Regulatorische Anforderungen an Medizinprodukte

Systemanforderungen an Medizinprodukte

Produktanforderungen an Medizinprodukte


4 Monate
2022-02 - 2022-05

QMR ISO 9001:2015

Qualitätsmanagementbeauftragter ISO 9001:2015, OTL Akademie
Qualitätsmanagementbeauftragter ISO 9001:2015
OTL Akademie
Qualitätsmanagementbeauftragter ISO 9001:2015
3 Monate
2021-02 - 2021-04

WERUM PAS-X Technical Training

Accenture
Accenture
WERUM PAS-X Technical Training for MBR Design
4 Monate
2020-12 - 2021-03

Angewandtes Datenmanagement

ANGEWANDTES DATENMANAGEMENT, ELG E-Learning Group
ANGEWANDTES DATENMANAGEMENT
ELG E-Learning Group

Digital Business

Neue Technologien

Data Science

Prozessdigitalisierung

Big Data und Künstliche Intelligenz

Informationsethik

7 Monate
2020-09 - 2021-03

Data Driven Consulting Program

Northwestern University
Northwestern University
1 Monat
2020-09 - 2020-09

Design Thinking Academy

Accenture
Accenture
5 Monate
2020-03 - 2020-07

Lean Six Sigma Black Belt

Lean Six Sigma Black Belt, C.S.S.C.
Lean Six Sigma Black Belt
C.S.S.C.
4 Monate
2019-02 - 2019-05

Technologie, Strategie und Leadership

MOOC house
MOOC house
1 Monat
2019-01 - 2019-01

Consulting University for Managers

Accenture
Accenture
4 Monate
2018-09 - 2018-12

Post gradual studies in ?Pharmaceutical Quality Management?

Qualified Person, University of Vienna, Austria
Qualified Person
University of Vienna, Austria
4 Monate
2017-06 - 2017-09

Process Mining: Data science in action

Corsera / Eindhoven University of Technology (TU/e)
Corsera / Eindhoven University of Technology (TU/e)
3 Monate
2017-03 - 2017-05

Big Data Analytics

open HPI
open HPI
5 Monate
2015-09 - 2016-01

Project Management Professional

PMP Project Management Professional, Project Management Institute
PMP Project Management Professional
Project Management Institute
6 Jahre 10 Monate
2006-04 - 2013-01

Study - Business Administration and Economics

Diploma, Distance University of Hagen, Germany
Diploma
Distance University of Hagen, Germany
3 Jahre 11 Monate
1999-01 - 2002-11

Promotion

Dr. rer. nat., Institute of Organic Chemistry, University of Tübingen, Germany
Dr. rer. nat.
Institute of Organic Chemistry, University of Tübingen, Germany
2 Jahre 6 Monate
1999-04 - 2001-09

Quantitative analysis and characterization of pharmaceutically and biochemically relevant substances

DFG Graduate Program
DFG Graduate Program
6 Jahre 4 Monate
1992-10 - 1999-01

Study - Chemistry

Diploma, University of Tübingen, Germany
Diploma
University of Tübingen, Germany
1 Jahr 1 Monat
1995-08 - 1996-08

Exchange study

University of Massachusetts at Amherst, MA, US
University of Massachusetts at Amherst, MA, US

Position

Position

  • Quality Management
  • Quality Control
  • Quality Assurance
  • Data Integrity
  • Interim Management
  • Project Management
  • Operational Excellence
  • Consulting

Kompetenzen

Kompetenzen

Top-Skills

GMP Quality Management Goal Directed Project Management Computer-Aided Quality Management Quality Control Quality Assurance Qualified Person Project Management PMP Quality Engineering Processautomation Process Management Lean Six Sigma Continuous Improvement CAPA Management Audit Management Change Control Digital Transformation Consulting

Produkte / Standards / Erfahrungen / Methoden

Profile
Competence: 20 years of hands-on experience in GMP, Quality, Manufacturing, Operational Excellence, Project Management and Digital Transformation in the API, Pharmaceutical and MedTech Industry

Career Objective
Provide service, advice and leadership for Quality 4.0 topics in Life Science

Skills
  • MS Office
    • Word
    • PowerPoint
    • Excel
  • Project Management SW
    • MS Project
    • Jira
  • PLM/ Technical Change Control SW
    • Polarion
  • Business Process SW
    • WERUM PAS-X (MES EBR)
    • SAP R/3
  • Statistical/ DoE/ Analytics SW
    • Minitab
    • Statgraphics
    • Stavex
  • Laboratory SW
    • LIMS
  • Quality Management Systems SW
    • EtQ
    • TrackWise
    • MasterControl
  • Document Management SW
    • Agile
    • Windchill
    • DHC

Qualitätssicherung

Quality Assurance
Quality Control
Quality Systems Engineer
Quality Management

Labor / Qualitätskontrolle

Head of QC
Head of Inspection and Testing (Med.Devices)

Produktion & Fertigung

API Manufacturing
Medical Device Manufacturing

Managementerfahrung in Unternehmen

Head of QC
Head of Quality
Head of Process Management
Project Management

Branchen

Branchen

  • Active Pharmaceutical Ingredients (API)
  • Pharmaceuticals (Bulk, FDF, Packaging)
  • Medical Devices (Class IIb, III)
  • Industry

Einsatzorte

Einsatzorte

München (+300km)
möglich

Projekte

Projekte

1 Monat
2024-04 - heute

Operational Excellence Consultant

Lean Management

Supporting a Medical Diagnostic Labs company in a Lean transformation program

Supporting the Lean Analysis Phase 

Driving local initiatives

Lean Management
amedes
Wasserburg (Bodensee)
6 Monate
2023-08 - 2024-01

Interim Head of Quality Control

Interim Head of Quality Control Quality Control Qualitymanagement Mitarbeiterführung ...
Interim Head of Quality Control

Interim Head of Quality Control acc. to AMG/AMWHV §12

Interim Management of QC Lab (30 FTE)

Interim Management of Analytical Development (5 FTE)

Start-up and Leadership of OOS Improvement Initiative

Pharma
Quality Control Qualitymanagement Mitarbeiterführung Interim Management
Advance Pharma
Berlin
2 Monate
2023-04 - 2023-05

Interim Project Lead QC Readiness

Interim Project Lead QC Readiness Quality Control Projektmanagement
Interim Project Lead QC Readiness

Support QC Readiness workstream in commercial readiness program (for uplift of GMP compliance, qualification of new QC lab, Anal. Method Transfer & Validation, QC Planning and scheduling system).

Biopharma
Quality Control Projektmanagement
Heidelberg (Germany)
3 Monate
2023-01 - 2023-03

PMO for Global QC team / Biopharma

PMO for Global QC team PMO Support Quality Control Good Manufacturing Practice
PMO for Global QC team
  • Act as Global QC PMO to support client Global QC organization in managing relevant portfolio of projects and initiatives
  • Define deliverables, participation to meetings with client Global QC staff and other functions, roadmap/ implementation plan definition, dashboarding/ periodic reporting on progress and completion of defined deliverables, identification and communication of issues and roadblocks to client Global QC and QA
  • Establish team progress monitoring & reporting governance
Vaccines Biopharma
PMO Support Quality Control Good Manufacturing Practice
Remote
11 Monate
2022-02 - 2022-12

QA Consultant / Project Manager

QA Consultant GMP Projektmanagement Pharma ...
QA Consultant
  • Project Lead for implementation of eQMS (MasterControl) and harmonization of QMS for Actylis EU (5 sites)
  • Creation of harmonized SOP?s for QMS
  • Trainer & System Administrator for MasterControl Go-live
  • Market release of Nutraceuticals, Fine Chemicals and API?s
MasterControl Pharma
GMP Projektmanagement Pharma Master Control QMS
Actylis (ex Aceto)
Remote
4 Monate
2021-09 - 2021-12

Head of Quality Unit / Pharma CMO

Head of Quality Unit CMOS Qualitymanagement Mitarbeiterführung
Head of Quality Unit
  • Responsible for Site Quality Unit (50+ FTE in QA & QC)
  • Ad-interim Head of QA (vacant position)
  • Ongoing Site Quality Remediation Management
  • Ongoing Quality Agreement Remediation Project 
  • Initiation and hands-on management of Overdue CAPA Remediation Project
  • Budgeting for Quality Unit
  • Lean QC efficiency project start-up, establishment of production planning-based forecast tool for QC workload
  • Staffing of vacant QA department roles and transition planning for key roles due to ongoing QA reorganization
  • Quality KPI reporting for local and global organization
  • Conduct of Quality Board and follow-up on action items
  • Assessment of compliance gaps and uplift of GMP level 
Pharma
CMOS Qualitymanagement Mitarbeiterführung
Swiss Caps GmbH/ Aenova Group, Bad Aibling (Germany)
Bad Aibling (Germany)
2 Jahre 8 Monate
2019-01 - 2021-08

Technology Consulting Principal

Technology Consulting Principal MES Design Control Projektmanagement ...
Technology Consulting Principal

2021-04 - 2021-07

  • Project Manager for biopharmaceutical manufacturing IT/OT assessment project, Global Biopharma client 


2021-02 - 2021-04

  • Subject Matter Expert for pharmaceutical manufacturing in Project ?Digital Performance Boards? ? Design and digital roadmap for a Continuous Manufacturing Digital Dashboard; Global Pharma client 


2019-10 -2019-12

  • Consulting services: Establishment of a Global MES System Technical Change Management process & SOP; Global Biopharma Client 


2020-07 - 2020-07

  • Subject Matter Expert for pharmaceutical quality business processes (QA, QC, QMS) in internal Project ?Digital Greenfield Reference Plant? 


2020-06 - 2020-06

  • Sub-Project Manager for workstreams Design Transfer, Design Changes, Service Tools in a complex, international MedTech R&D Project; Global MedTech Client


2019-02 - 2019-04

  • Consulting services: Ad-interim Project Governance for a Global MES Implementation Project in a pharma manufacturing plant in China (remote); Global Biopharma Client
  • Business development, sales support and solution selling

Werum IT Solutions Medizinprodukte Pharma
MES Design Control Projektmanagement Beratung
Accenture GmbH, Office Munich (Germany)
Germany
2 Jahre 5 Monate
2016-08 - 2018-12

Senior Consultant - Quality Consulting Services for Life Sciences Clients

Senior Consultant - Life Sciences Qualitätsengineering Qualitätsprüfung Beratung ...
Senior Consultant - Life Sciences
2018-09 - 2018-12

  • Consulting services: Senior Quality Systems Engineer ? Overdue CAPA & Audit Observation Remediation for Global MedTech Client


2016-09 - 2018-09

  • Quality Systems Engineer for DePuy Synthes, Plant Salzburg, Austria, labor leasing contract


2016-08 - 2019-09

  • Consulting service for Utilities Qualification Project; Global  Biopharma Client

  • Sales support in business closing and solution selling
  • German coordinator for Altran-internal international knowledge sharing transfer program (PULSE)
  • SPOC for Biopharmaceutical Industry client (interviewing, staffing and placement of consultants)

Medizinprodukte
Qualitätsengineering Qualitätsprüfung Beratung Performance Qualification CAPA
Altran S.A.S. & Co. KG, Munich, Germany
Salzburg, Wien, Tuttlingen, München
2 Jahre
2016-09 - 2018-08

Quality System Engineer / Medical Devices

Quality System Engineer DIN 13485 Qualitymanagement Quality Control ...
Quality System Engineer
  • Responsible for local QMS system implementation, maintenance, and continuous improvement; coordination of Quality Team Inspection and Test (4 FTE); audit readiness and audit observation / CAPA coordination; investigation and escalation of quality issues
Medizinprodukte
DIN 13485 Qualitymanagement Quality Control Audit
DePuy Synthes Österreich GmbH, Salzburg, Austria
Salzburg, Austria
4 Jahre 4 Monate
2012-04 - 2016-07

Project Management Operational Excellence / Pharma

Project Manager Operational Excellence Projektmanagement Lean Management Operational Excellence ...
Project Manager Operational Excellence
2013-01 - 2016-07

  • Project Manager for MES EBR Rollout Project: Deployment of WERUM PAS-X MES system for approx. 900 TechOps end users: leading a cross-functional project team of 2-10 FTE; managing 2,4 Mio? budget; implementing required hardware, software changes, end-user training & buy-in for electronic batch recording (paper-on-glass approach) in pharma manufacturing


2012-04 - 2013-01

  • Project Manager for TechOps Lean Transformation Project in Sterile FDF Production as follow-up of a McKinsey study: Leading a cross-functional project team of approx
  • 5 FTE for evaluation and implementation of various LEAN tools, methods and processes on the shopfloor, employee mindset change and buy-in for LEAN principles
  • Lean Six Sigma Program initiation and deployment in TechOps
  • Employee suggestion system coordinator for TechOps

Pharma Werum IT Solutions
Projektmanagement Lean Management Operational Excellence MES Programmmanagement Kontinuierlicher Verbesserungsprozess
TechOps, Sandoz GmbH, Kundl (Austria)
Kundl (Austria)
1 Jahr 5 Monate
2010-11 - 2012-03

Head Global Process Management

Head Global Process Management Kontinuierlicher Verbesserungsprozess Lean Management Projektmanagement ...
Head Global Process Management
  • Providing technical support, monitoring performance, and driving continuous improvement initiatives and projects for Sandoz Global Manufacturing Network Anti-Infectives (7 European sites, 1 Asian site)
  • Change Agent for Global Lean Six Sigma Program deployment in Sandoz Business Unit Anti-Infectives 
  • Project Manager for ?Theoretical Limit in Energy Management? pilot project at Sandoz Site Frankfurt 01-03/2012: hands-on feasibility study of McKinsey methodology, identification, and evaluation of yet unknown levers for energy savings (approx. 500 k? p.a. potential identified with payback < 2 years)
Pharma Active Pharmaceutical Ingredients
Kontinuierlicher Verbesserungsprozess Lean Management Projektmanagement Stakeholdermanagement Operational Excellence
Sandoz GmbH, Kundl (Austria)
2 Jahre 9 Monate
2008-02 - 2010-10

Head of IPC/QC Analytical & Technical Process Support Labs

Head IPC/QC Analytical & Technical Process Support Laboratory Good Manufacturing Practice Quality Control Mitarbeiterführung ...
Head IPC/QC Analytical & Technical Process Support Laboratory
  • People lead of 12 lab associates in a QC laboratory
  • Technical process improvement & troubleshooting of API manufacturing processes
  • Analytics, QC, IPC of raw materials, intermediates, API's and FDF's
  • analytical methods including e.g. pharmaceutical water analysis, HPLC, GC, GPC, UV/VIS, enzymatic methods, physical characteristics, electrophoresis
Active Pharmaceutical Ingredients Pharma
Good Manufacturing Practice Quality Control Mitarbeiterführung Prozessentwicklung
Sandoz GmbH, Schaftenau (Austria)
Schaftenau (Austria)
5 Jahre 1 Monat
2003-01 - 2008-01

Head of IPC/QC Analytical Laboratory

Head IPC/QC Analytical Laboratory Good Manufacturing Practice Quality Control Mitarbeiterführung
Head IPC/QC Analytical Laboratory
  • People lead of 8 lab associates in a QC laboratory
  • Uplift of GMP level to ongoing inspection readiness
  • Analytics, QC, IPC of raw materials, intermediates, API's
  • analytical methods including e.g. pharmaceutical water analysis, HPLC, GC, UV/VIS, enzymatic methods, physical characteristics
  • Information security coordinator; SAP business super user
Pharma
Good Manufacturing Practice Quality Control Mitarbeiterführung
Sandoz GmbH, Schaftenau (Austria)

Aus- und Weiterbildung

Aus- und Weiterbildung

2 Jahre 4 Monate
2022-03 - 2024-06

MasterControl SysAdmin

Hybrid online training, MasterControl
Hybrid online training, MasterControl
2 Monate
2024-01 - 2024-02

open HPI Winterschool (AI & Maschinelles Lernen)

openHPI
openHPI

Künstliche Intelligenz und Maschinelles Lernen für Einsteiger

Künstliche Intelligenz und Maschinelles Lernen in der Praxis

ChatGPT: Was bedeutet generative KI für unsere Gesellschaft?

KI und Datenqualität - Perspektiven aus Data Science, Ethik, Normung und Recht

3 Monate
2023-06 - 2023-08

Lead Auditor ISO 13485 & ISO 17025

Lead Auditor ISO 13485 & ISO 17025, Exemplar Global
Lead Auditor ISO 13485 & ISO 17025
Exemplar Global
1 Jahr
2022-01 - 2022-12

Manager Regulatory Affairs

Manager Regulatory Affairs, TH / Uni Lübeck
Manager Regulatory Affairs
TH / Uni Lübeck

Regulatorische Anforderungen an Medizinprodukte

Systemanforderungen an Medizinprodukte

Produktanforderungen an Medizinprodukte


4 Monate
2022-02 - 2022-05

QMR ISO 9001:2015

Qualitätsmanagementbeauftragter ISO 9001:2015, OTL Akademie
Qualitätsmanagementbeauftragter ISO 9001:2015
OTL Akademie
Qualitätsmanagementbeauftragter ISO 9001:2015
3 Monate
2021-02 - 2021-04

WERUM PAS-X Technical Training

Accenture
Accenture
WERUM PAS-X Technical Training for MBR Design
4 Monate
2020-12 - 2021-03

Angewandtes Datenmanagement

ANGEWANDTES DATENMANAGEMENT, ELG E-Learning Group
ANGEWANDTES DATENMANAGEMENT
ELG E-Learning Group

Digital Business

Neue Technologien

Data Science

Prozessdigitalisierung

Big Data und Künstliche Intelligenz

Informationsethik

7 Monate
2020-09 - 2021-03

Data Driven Consulting Program

Northwestern University
Northwestern University
1 Monat
2020-09 - 2020-09

Design Thinking Academy

Accenture
Accenture
5 Monate
2020-03 - 2020-07

Lean Six Sigma Black Belt

Lean Six Sigma Black Belt, C.S.S.C.
Lean Six Sigma Black Belt
C.S.S.C.
4 Monate
2019-02 - 2019-05

Technologie, Strategie und Leadership

MOOC house
MOOC house
1 Monat
2019-01 - 2019-01

Consulting University for Managers

Accenture
Accenture
4 Monate
2018-09 - 2018-12

Post gradual studies in ?Pharmaceutical Quality Management?

Qualified Person, University of Vienna, Austria
Qualified Person
University of Vienna, Austria
4 Monate
2017-06 - 2017-09

Process Mining: Data science in action

Corsera / Eindhoven University of Technology (TU/e)
Corsera / Eindhoven University of Technology (TU/e)
3 Monate
2017-03 - 2017-05

Big Data Analytics

open HPI
open HPI
5 Monate
2015-09 - 2016-01

Project Management Professional

PMP Project Management Professional, Project Management Institute
PMP Project Management Professional
Project Management Institute
6 Jahre 10 Monate
2006-04 - 2013-01

Study - Business Administration and Economics

Diploma, Distance University of Hagen, Germany
Diploma
Distance University of Hagen, Germany
3 Jahre 11 Monate
1999-01 - 2002-11

Promotion

Dr. rer. nat., Institute of Organic Chemistry, University of Tübingen, Germany
Dr. rer. nat.
Institute of Organic Chemistry, University of Tübingen, Germany
2 Jahre 6 Monate
1999-04 - 2001-09

Quantitative analysis and characterization of pharmaceutically and biochemically relevant substances

DFG Graduate Program
DFG Graduate Program
6 Jahre 4 Monate
1992-10 - 1999-01

Study - Chemistry

Diploma, University of Tübingen, Germany
Diploma
University of Tübingen, Germany
1 Jahr 1 Monat
1995-08 - 1996-08

Exchange study

University of Massachusetts at Amherst, MA, US
University of Massachusetts at Amherst, MA, US

Position

Position

  • Quality Management
  • Quality Control
  • Quality Assurance
  • Data Integrity
  • Interim Management
  • Project Management
  • Operational Excellence
  • Consulting

Kompetenzen

Kompetenzen

Top-Skills

GMP Quality Management Goal Directed Project Management Computer-Aided Quality Management Quality Control Quality Assurance Qualified Person Project Management PMP Quality Engineering Processautomation Process Management Lean Six Sigma Continuous Improvement CAPA Management Audit Management Change Control Digital Transformation Consulting

Produkte / Standards / Erfahrungen / Methoden

Profile
Competence: 20 years of hands-on experience in GMP, Quality, Manufacturing, Operational Excellence, Project Management and Digital Transformation in the API, Pharmaceutical and MedTech Industry

Career Objective
Provide service, advice and leadership for Quality 4.0 topics in Life Science

Skills
  • MS Office
    • Word
    • PowerPoint
    • Excel
  • Project Management SW
    • MS Project
    • Jira
  • PLM/ Technical Change Control SW
    • Polarion
  • Business Process SW
    • WERUM PAS-X (MES EBR)
    • SAP R/3
  • Statistical/ DoE/ Analytics SW
    • Minitab
    • Statgraphics
    • Stavex
  • Laboratory SW
    • LIMS
  • Quality Management Systems SW
    • EtQ
    • TrackWise
    • MasterControl
  • Document Management SW
    • Agile
    • Windchill
    • DHC

Qualitätssicherung

Quality Assurance
Quality Control
Quality Systems Engineer
Quality Management

Labor / Qualitätskontrolle

Head of QC
Head of Inspection and Testing (Med.Devices)

Produktion & Fertigung

API Manufacturing
Medical Device Manufacturing

Managementerfahrung in Unternehmen

Head of QC
Head of Quality
Head of Process Management
Project Management

Branchen

Branchen

  • Active Pharmaceutical Ingredients (API)
  • Pharmaceuticals (Bulk, FDF, Packaging)
  • Medical Devices (Class IIb, III)
  • Industry

Vertrauen Sie auf GULP

Im Bereich Freelancing
Im Bereich Arbeitnehmerüberlassung / Personalvermittlung

Fragen?

Rufen Sie uns an +49 89 500316-300 oder schreiben Sie uns:

Das GULP Freelancer-Portal

Direktester geht's nicht! Ganz einfach Freelancer finden und direkt Kontakt aufnehmen.