Sachkundige Person nach AMG mit LQK und LQS Hintergrund
Aktualisiert am 23.04.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 23.04.2024
Verfügbar zu: 100%
davon vor Ort: 100%
Sachkundige Person
Qualitätssicherung
Qualitymanagement
Deviation Management
CAPA Management
Batch Record Review
English
fluent
French
basic knowledge

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

4 Monate
2024-01 - heute

Various projects

Chief Executive Officer (CEO)
Chief Executive Officer (CEO)
Pharmapotheken Solution GmbH
3 Jahre 1 Monat
2021-01 - 2024-01

Quality assurance management

  • Quality assurance management
  • Qualified person for internally manufactured solid dosage forms
  • Participation in audits by authorities and customers
  • Participation in change management and evaluation of deviations, CAPAs and complaints
  • Preparation/Review of product quality reviews
  • Development of the Q-system and ensuring compliance with current
  • EU laws and directives
Bayer AG
2 Jahre
2019-02 - 2021-01

Project management

Project Manager
Project Manager
  • Deviation and CAPA management
  • Quality assurance management
  • Project management (Boehringer Ingelheim)
MJD-Consulting GmbH
10 Monate
2018-04 - 2019-01

Improvement of a quality assurance system

Head of Quality Assurance/Qualified Person
Head of Quality Assurance/Qualified Person
  • Qualified Person
  • Head of Quality Assurance DACH region
  • Management of pharmaceutical warehouse
  • Negotiation of quality agreements on global level
  • Improvement of a quality assurance system (GDP /GMP)
Azelis Deutschland Pharma GmbH
3 Jahre 3 Monate
2015-01 - 2018-03

Operative business management

Head Quality Control/Qualified Person
Head Quality Control/Qualified Person
  • operative business management quality control lab
  • Qualified Person acc. AMG
  • Overview stability studies
  • business-concept new technologies
  • support/management deviation/complaint management
  • relationships to authorities regarding quality control
Dyckerhoff Pharma GmbH & Co KG
6 Monate
2014-07 - 2014-12

QA CMO Management

  • CMO quality assurance management
  • ChangeControl und CAPA-Management required by CMO
  • Support QP function
  • Complaint/deviation management for CMO issues
  • client management
Aesica Pharmaceuticals GmbH
10 Monate
2013-09 - 2014-06

Support management

Head of Quality Control
Head of Quality Control
  • Head of Quality Control acc. AMG
  • Cost center management
  • Improvement concept quality control
  • Support management
DBU-Blisterzentrum Rheinland
3 Jahre 1 Monat
2010-08 - 2013-08

Development of quality assurance system

  • Responsibility for narcotics
  • Consulting service for patience
  • Development of quality assurance system
Pinguin Apotheken Leverkusen

Aus- und Weiterbildung

Aus- und Weiterbildung

2010 - 2015:

Medizinische Klinik I der Universität zu Köln

doctoral thesis


2008:

Universität Limoges

degree pogramm: Erasmus

Semester am centre hospitalier et universitaire de Limoges


2004 - 2009:

Universität zu Bonn

degree pogramm: Pharmacie (graduation Approbation)


1994 - 2003:

Humbold Gymnasium Köln

school education


1990 - 1994:

primary school Cologne

school education

Kompetenzen

Kompetenzen

Top-Skills

Sachkundige Person Qualitätssicherung Qualitymanagement Deviation Management CAPA Management Batch Record Review

Produkte / Standards / Erfahrungen / Methoden

SAP (P2R/batch release)
PAS X (Werum/HPs)
PAS X (DEV@COM/Deviation)
pmxp1 (EBR)
PharmDoss (TRD's)
MS-Office
Graph Pad Prism
Blimus
Pharmatechnik

Profil:

Pharmaceutical industry

  • 10 years experience in different management roles  
  • Serving for all different segments of the industry:
  • Contract Development and Manufacturing, Generics and Originator


Management expertise

  • Cost center management 
  • Head of Quality Assurance up to 4 people
  • Head of Quality Control laboratory up to 5 people
  • Project Management


Technical experience

  • 4 years analytical knowledge 
  • with solid, semi solid, liquid dosage forms
  • QP-function, Head of Quality Control
  • Head of Quality Assurance: ChangeControl
  • Complaint management, Deviation Management, CAPA etc.
  • Negotiation of quality agreements
  • Analytics of phythopharmaceuticals incl. HPLC, GC etc
  • Handling of QA-systems within DMS-system and Trackwise

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

4 Monate
2024-01 - heute

Various projects

Chief Executive Officer (CEO)
Chief Executive Officer (CEO)
Pharmapotheken Solution GmbH
3 Jahre 1 Monat
2021-01 - 2024-01

Quality assurance management

  • Quality assurance management
  • Qualified person for internally manufactured solid dosage forms
  • Participation in audits by authorities and customers
  • Participation in change management and evaluation of deviations, CAPAs and complaints
  • Preparation/Review of product quality reviews
  • Development of the Q-system and ensuring compliance with current
  • EU laws and directives
Bayer AG
2 Jahre
2019-02 - 2021-01

Project management

Project Manager
Project Manager
  • Deviation and CAPA management
  • Quality assurance management
  • Project management (Boehringer Ingelheim)
MJD-Consulting GmbH
10 Monate
2018-04 - 2019-01

Improvement of a quality assurance system

Head of Quality Assurance/Qualified Person
Head of Quality Assurance/Qualified Person
  • Qualified Person
  • Head of Quality Assurance DACH region
  • Management of pharmaceutical warehouse
  • Negotiation of quality agreements on global level
  • Improvement of a quality assurance system (GDP /GMP)
Azelis Deutschland Pharma GmbH
3 Jahre 3 Monate
2015-01 - 2018-03

Operative business management

Head Quality Control/Qualified Person
Head Quality Control/Qualified Person
  • operative business management quality control lab
  • Qualified Person acc. AMG
  • Overview stability studies
  • business-concept new technologies
  • support/management deviation/complaint management
  • relationships to authorities regarding quality control
Dyckerhoff Pharma GmbH & Co KG
6 Monate
2014-07 - 2014-12

QA CMO Management

  • CMO quality assurance management
  • ChangeControl und CAPA-Management required by CMO
  • Support QP function
  • Complaint/deviation management for CMO issues
  • client management
Aesica Pharmaceuticals GmbH
10 Monate
2013-09 - 2014-06

Support management

Head of Quality Control
Head of Quality Control
  • Head of Quality Control acc. AMG
  • Cost center management
  • Improvement concept quality control
  • Support management
DBU-Blisterzentrum Rheinland
3 Jahre 1 Monat
2010-08 - 2013-08

Development of quality assurance system

  • Responsibility for narcotics
  • Consulting service for patience
  • Development of quality assurance system
Pinguin Apotheken Leverkusen

Aus- und Weiterbildung

Aus- und Weiterbildung

2010 - 2015:

Medizinische Klinik I der Universität zu Köln

doctoral thesis


2008:

Universität Limoges

degree pogramm: Erasmus

Semester am centre hospitalier et universitaire de Limoges


2004 - 2009:

Universität zu Bonn

degree pogramm: Pharmacie (graduation Approbation)


1994 - 2003:

Humbold Gymnasium Köln

school education


1990 - 1994:

primary school Cologne

school education

Kompetenzen

Kompetenzen

Top-Skills

Sachkundige Person Qualitätssicherung Qualitymanagement Deviation Management CAPA Management Batch Record Review

Produkte / Standards / Erfahrungen / Methoden

SAP (P2R/batch release)
PAS X (Werum/HPs)
PAS X (DEV@COM/Deviation)
pmxp1 (EBR)
PharmDoss (TRD's)
MS-Office
Graph Pad Prism
Blimus
Pharmatechnik

Profil:

Pharmaceutical industry

  • 10 years experience in different management roles  
  • Serving for all different segments of the industry:
  • Contract Development and Manufacturing, Generics and Originator


Management expertise

  • Cost center management 
  • Head of Quality Assurance up to 4 people
  • Head of Quality Control laboratory up to 5 people
  • Project Management


Technical experience

  • 4 years analytical knowledge 
  • with solid, semi solid, liquid dosage forms
  • QP-function, Head of Quality Control
  • Head of Quality Assurance: ChangeControl
  • Complaint management, Deviation Management, CAPA etc.
  • Negotiation of quality agreements
  • Analytics of phythopharmaceuticals incl. HPLC, GC etc
  • Handling of QA-systems within DMS-system and Trackwise

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