GxP consulting, interim FvP, Qualified Person, inspection readiness, GMP training of staff
Aktualisiert am 27.08.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 24.08.2024
Verfügbar zu: 60%
davon vor Ort: 50%
Good Manufacturing Practice
Fachtechnisch verantwortliche Person
Beratung
Trainer
ISO 9001
ISO 22000
Good Distribution Practice
DIN 13485
Medizinprodukte
Cross functional team
agiles Projektmanagement
Inspection readiness
Audit
English
Proficient in written and spoken
German
Bilingual
French
Bilingual

Einsatzorte

Einsatzorte

Schweiz
möglich

Projekte

Projekte

2021 - today: Consultancy services on GMP/GDP and QP (FvP)


Role: Consultant

Customer: several clients (Lonza AG (Moderna), Celonic, Swissfillon, HEMEX)


Tasks:

  • (document management, CAPA, change control, deviation handling, product release, specification maintenance, supplier qualifications, quality assurance agreements)
  • Acting as intermediate QP (FvP)
  • mRNA vaccine tech transfer / development of the QA (mRNA vaccine, Lonza AG)
  • Consulting on contamination control strategy
  • Management of internal and external audits; execution of supplier and service provider qualifications
  • Consulting on regulatory issues (Regulatory Affairs)
  • GMP training of staff

2015 - 2020: Developed the two manufacturing sites


Role: Head of Quality Management, Qualified Person, FvP (Member of the Board)

Customer: Alcosuisse AG, Berne, Switzerland


Tasks:

Alcosuisse AG offers GMP-manufacturing of ethanol qualities and specialties for pharmaceutical, chemical, cosmetic and food industry

  • Developed the two manufacturing sites to acquire the GMP manufacturing license
  • Decision on batch release and certification
  • Briefing and developing the quality management team to fulfill the daily Quality Assurance tasks (document management, CAPA, Change Control, deviation handling, product release, quality trainings, product quality questionnaire, quality agreements)
  • Responsible for the entire quality assurance system according to ISO 9001:2015; ISO 22000 and other quality relevant certifications, regulations or labels (HACCP, food regulation, etc.)
  • Main lead on the organoleptic testing lab
  • Managing of internal and external audits, resp. inspections
  • Main contact for internal and external questions of quality, regulatory (REACH, Biozid) or scientifically nature.

2011 - 2015: Develop and maintain the quality management system


Role: Head of Quality Systems (Member of the Management Team)

Customer: Finox AG, Burgdorf, Switzerland


Tasks:

Head of Quality Systems (Member of the Management Team), 2012 to 2015

  • Deputy of Qualified Person, FvP
  • Develop and maintain the quality management system according to cGMP (PIC/S) and ISO as well as the requirements for drug approval holders by Swissmedic, EMEA and the FDA
  • Report to the QP the performance of the Q-systems and necessary improvements
  • Develop, expand, and monitor the contractors on agreed quality assurance for clinical development, API and drug product manufacturing and supply chain
  • Organization of inspections (self-inspections, regulatory inspections, etc.)
  • Responsible for external contacts with partners in terms of quality assurance, inspections and cGMP
  • Organize, supervise the editing of controlled documents (documentation control) within the cGMP environment
  • Provide expert opinion on internal, external issues, publications related to cGMP and / or quality assurance
  • Negotiating contracts like service and quality agreements
  • Monitoring the cGMP status of the pharmaceutical manufacturing
  • Consulting Supplier on project related technology transfer and process validation
  • Auditing and evaluation of supplier

2008 - 2010: Briefing and developing the core project management team


Role: Head of Project Management (Member of the Board)

Customer: Recipharm AG, Basel


Tasks:

  • Recipharm was Contract Developing and Manufacturing Organization (CDMO)
  • Briefing and developing the core project management team
  • Day-to-day running of multiple projects through the entire project lifecycle, completion of projects within schedule and budget, align projects with QA compliance
  • Preparing bidding document according to the requirement of client; contract negotiation; technical clarification with client or suppliers
  • Manage the interdependencies between organizational strategies, strategic business plans, projects portfolio, project programs and projects
  • Reporting to the CEO and implementation of new strategic directions
  • Marketing assessments to identify target markets
  • Relationship marketing; customer and competitive intelligence gathering
2005 - 2008: Organized and performed staff training, managed validation work


Role: Head Filling & Lyophilization, Head Downstream Processing

Customer: Crucell, Berne, Switzerland


Tasks:

  • Former vaccine developing and manufacturing organization Berna Biotec


Head Filling & Lyophilization, Department of ?Live Viral Vaccines?, 2006-2008:

  • Lead, developed and ensured the qualification of the core team for a qualitative and quantitative flawless production of vaccines (measles, rubella, yellow fever) in strict compliance with GMP
  • Organized and performed staff training, managed validation work
  • Supervised clean room and media monitoring
  • Wrote, managed and trained staff on SOPs
  • Production batch protocol review, managed production environment on SAP-system
  • Guided and directed site inspections of WHO and Swissmedic


Head Downstream Processing, Department of ?Early Process Development?, 2005-2006

  • Project leader DSP
  • Responsibility in the design of purification processes
  • Coordinated operations with the Upstream Processing and Bioanalytics department
  • Sound knowledge in chromatographic purification and polishing steps and protein analytics

2002 - 2005: Worked in a Bio Safety Level 3 facility (BSL3)


Role: Study director

Customer: CSL Behring and Veterans Affairs Medical Health Center (VAMHCS), Berne and Baltimore


Tasks:

  • Stage in USA on behalf of CSL Behring: Wrote study protocols, performed and evaluated TSE removal studies in plasma fractionation. Wrote final report
  • Worked in a Bio Safety Level 3 facility (BSL3) following strict SOP?s developed to optimize precision and maintaining safety while working with the infectious agent
  • Performed blood fractionation, process down scaling and virus validation
  • Performed viral validation studies according to GLP/GMP. Fractionated plasma in small- and laboratory scale
  • Worked according GLP and GCP
1994 - 2002:


Role: Research deputy

Customer: University of Berne, Berne, Switzerland


Tasks:

Research deputy, Department of Chemistry and Biochemistry, University of Berne, 1998-2002:

  • Research deputy in mass spectrometry of Prof. J. Schaller (Director of Analytical Research Service (ARS))
  • Proficient knowledge in protein analysis by mass spectrometry, protein sequencing, HPLC and different analysis apparatuses

Aus- und Weiterbildung

Aus- und Weiterbildung

2003 - 2005:

Postdoctoral Research

Veterans Affairs Medical Center (VAMHCS), Baltimore (MD), USA


Key Focus:

Postdoctoral Research, Research advisor: [Name on request]

  • Post Doc in the Molecular Neurovirology Laboratory: Area of specialization: Transmissible Spongiform Encephalopathies
  • Cloning, Recombinant expression and purification of Prion proteins
  • Development of diagnostic assays, investigative studies of the infectious agent (Transmissible Spongiform Encephalopathies (TSEs))


1994 - 2002:

Doctoral Research

University of Berne, Berne, Switzerland


Key Focus:

Doctoral Research, Research advisor: [Name on request]

  • Ph.D. in Biochemistry, 2002
  • Recombinant expression, binding studies and structure resolution (by means of NMR) of different constructs of the ?2-Plasmin inhibitor and Plasminogen (Collaboration with Prof. Miguel Llinás (Department of Chemistry, Carnegie Mellon University, Pittsburgh))


Undergraduate Research, Research advisor: [Name on request]

  • B.S. in Biochemistry, 1998
  • Isolation of blood proteins
  • Cloning, recombinant expression, isolation and analysis of the c-terminal part of the 2-Plasmin inhibitor

Kompetenzen

Kompetenzen

Top-Skills

Good Manufacturing Practice Fachtechnisch verantwortliche Person Beratung Trainer ISO 9001 ISO 22000 Good Distribution Practice DIN 13485 Medizinprodukte Cross functional team agiles Projektmanagement Inspection readiness Audit

Produkte / Standards / Erfahrungen / Methoden

Teaching Experience

2003 - 2005:

Role: Instructor

Customer: VAMHCS


Tasks:

  • Trained technicians in protein analytics (HPLC, MS, ?) and protein expression, purification


1999 - 2002:

Role: Instructor

Customer: University of Berne


Tasks:

  • Practice trainer, demonstrated techniques and assisted students in laboratory routines


1997 - 1997:

Role: Deputy Instructor

Customer: Colleges of Burgdorf and Köniz, Switzerland


Tasks:

  • Lectures in Chemistry


IT-Systems

  • ERP-Systems (SAP, JDE, Microsoft Navision)
  • Document management system, Deviation, CAPA and Change Control handling (Trackwise, Vivaldi, Veeva, DMS)
  • LIMS
  • WorkDay

Einsatzorte

Einsatzorte

Schweiz
möglich

Projekte

Projekte

2021 - today: Consultancy services on GMP/GDP and QP (FvP)


Role: Consultant

Customer: several clients (Lonza AG (Moderna), Celonic, Swissfillon, HEMEX)


Tasks:

  • (document management, CAPA, change control, deviation handling, product release, specification maintenance, supplier qualifications, quality assurance agreements)
  • Acting as intermediate QP (FvP)
  • mRNA vaccine tech transfer / development of the QA (mRNA vaccine, Lonza AG)
  • Consulting on contamination control strategy
  • Management of internal and external audits; execution of supplier and service provider qualifications
  • Consulting on regulatory issues (Regulatory Affairs)
  • GMP training of staff

2015 - 2020: Developed the two manufacturing sites


Role: Head of Quality Management, Qualified Person, FvP (Member of the Board)

Customer: Alcosuisse AG, Berne, Switzerland


Tasks:

Alcosuisse AG offers GMP-manufacturing of ethanol qualities and specialties for pharmaceutical, chemical, cosmetic and food industry

  • Developed the two manufacturing sites to acquire the GMP manufacturing license
  • Decision on batch release and certification
  • Briefing and developing the quality management team to fulfill the daily Quality Assurance tasks (document management, CAPA, Change Control, deviation handling, product release, quality trainings, product quality questionnaire, quality agreements)
  • Responsible for the entire quality assurance system according to ISO 9001:2015; ISO 22000 and other quality relevant certifications, regulations or labels (HACCP, food regulation, etc.)
  • Main lead on the organoleptic testing lab
  • Managing of internal and external audits, resp. inspections
  • Main contact for internal and external questions of quality, regulatory (REACH, Biozid) or scientifically nature.

2011 - 2015: Develop and maintain the quality management system


Role: Head of Quality Systems (Member of the Management Team)

Customer: Finox AG, Burgdorf, Switzerland


Tasks:

Head of Quality Systems (Member of the Management Team), 2012 to 2015

  • Deputy of Qualified Person, FvP
  • Develop and maintain the quality management system according to cGMP (PIC/S) and ISO as well as the requirements for drug approval holders by Swissmedic, EMEA and the FDA
  • Report to the QP the performance of the Q-systems and necessary improvements
  • Develop, expand, and monitor the contractors on agreed quality assurance for clinical development, API and drug product manufacturing and supply chain
  • Organization of inspections (self-inspections, regulatory inspections, etc.)
  • Responsible for external contacts with partners in terms of quality assurance, inspections and cGMP
  • Organize, supervise the editing of controlled documents (documentation control) within the cGMP environment
  • Provide expert opinion on internal, external issues, publications related to cGMP and / or quality assurance
  • Negotiating contracts like service and quality agreements
  • Monitoring the cGMP status of the pharmaceutical manufacturing
  • Consulting Supplier on project related technology transfer and process validation
  • Auditing and evaluation of supplier

2008 - 2010: Briefing and developing the core project management team


Role: Head of Project Management (Member of the Board)

Customer: Recipharm AG, Basel


Tasks:

  • Recipharm was Contract Developing and Manufacturing Organization (CDMO)
  • Briefing and developing the core project management team
  • Day-to-day running of multiple projects through the entire project lifecycle, completion of projects within schedule and budget, align projects with QA compliance
  • Preparing bidding document according to the requirement of client; contract negotiation; technical clarification with client or suppliers
  • Manage the interdependencies between organizational strategies, strategic business plans, projects portfolio, project programs and projects
  • Reporting to the CEO and implementation of new strategic directions
  • Marketing assessments to identify target markets
  • Relationship marketing; customer and competitive intelligence gathering
2005 - 2008: Organized and performed staff training, managed validation work


Role: Head Filling & Lyophilization, Head Downstream Processing

Customer: Crucell, Berne, Switzerland


Tasks:

  • Former vaccine developing and manufacturing organization Berna Biotec


Head Filling & Lyophilization, Department of ?Live Viral Vaccines?, 2006-2008:

  • Lead, developed and ensured the qualification of the core team for a qualitative and quantitative flawless production of vaccines (measles, rubella, yellow fever) in strict compliance with GMP
  • Organized and performed staff training, managed validation work
  • Supervised clean room and media monitoring
  • Wrote, managed and trained staff on SOPs
  • Production batch protocol review, managed production environment on SAP-system
  • Guided and directed site inspections of WHO and Swissmedic


Head Downstream Processing, Department of ?Early Process Development?, 2005-2006

  • Project leader DSP
  • Responsibility in the design of purification processes
  • Coordinated operations with the Upstream Processing and Bioanalytics department
  • Sound knowledge in chromatographic purification and polishing steps and protein analytics

2002 - 2005: Worked in a Bio Safety Level 3 facility (BSL3)


Role: Study director

Customer: CSL Behring and Veterans Affairs Medical Health Center (VAMHCS), Berne and Baltimore


Tasks:

  • Stage in USA on behalf of CSL Behring: Wrote study protocols, performed and evaluated TSE removal studies in plasma fractionation. Wrote final report
  • Worked in a Bio Safety Level 3 facility (BSL3) following strict SOP?s developed to optimize precision and maintaining safety while working with the infectious agent
  • Performed blood fractionation, process down scaling and virus validation
  • Performed viral validation studies according to GLP/GMP. Fractionated plasma in small- and laboratory scale
  • Worked according GLP and GCP
1994 - 2002:


Role: Research deputy

Customer: University of Berne, Berne, Switzerland


Tasks:

Research deputy, Department of Chemistry and Biochemistry, University of Berne, 1998-2002:

  • Research deputy in mass spectrometry of Prof. J. Schaller (Director of Analytical Research Service (ARS))
  • Proficient knowledge in protein analysis by mass spectrometry, protein sequencing, HPLC and different analysis apparatuses

Aus- und Weiterbildung

Aus- und Weiterbildung

2003 - 2005:

Postdoctoral Research

Veterans Affairs Medical Center (VAMHCS), Baltimore (MD), USA


Key Focus:

Postdoctoral Research, Research advisor: [Name on request]

  • Post Doc in the Molecular Neurovirology Laboratory: Area of specialization: Transmissible Spongiform Encephalopathies
  • Cloning, Recombinant expression and purification of Prion proteins
  • Development of diagnostic assays, investigative studies of the infectious agent (Transmissible Spongiform Encephalopathies (TSEs))


1994 - 2002:

Doctoral Research

University of Berne, Berne, Switzerland


Key Focus:

Doctoral Research, Research advisor: [Name on request]

  • Ph.D. in Biochemistry, 2002
  • Recombinant expression, binding studies and structure resolution (by means of NMR) of different constructs of the ?2-Plasmin inhibitor and Plasminogen (Collaboration with Prof. Miguel Llinás (Department of Chemistry, Carnegie Mellon University, Pittsburgh))


Undergraduate Research, Research advisor: [Name on request]

  • B.S. in Biochemistry, 1998
  • Isolation of blood proteins
  • Cloning, recombinant expression, isolation and analysis of the c-terminal part of the 2-Plasmin inhibitor

Kompetenzen

Kompetenzen

Top-Skills

Good Manufacturing Practice Fachtechnisch verantwortliche Person Beratung Trainer ISO 9001 ISO 22000 Good Distribution Practice DIN 13485 Medizinprodukte Cross functional team agiles Projektmanagement Inspection readiness Audit

Produkte / Standards / Erfahrungen / Methoden

Teaching Experience

2003 - 2005:

Role: Instructor

Customer: VAMHCS


Tasks:

  • Trained technicians in protein analytics (HPLC, MS, ?) and protein expression, purification


1999 - 2002:

Role: Instructor

Customer: University of Berne


Tasks:

  • Practice trainer, demonstrated techniques and assisted students in laboratory routines


1997 - 1997:

Role: Deputy Instructor

Customer: Colleges of Burgdorf and Köniz, Switzerland


Tasks:

  • Lectures in Chemistry


IT-Systems

  • ERP-Systems (SAP, JDE, Microsoft Navision)
  • Document management system, Deviation, CAPA and Change Control handling (Trackwise, Vivaldi, Veeva, DMS)
  • LIMS
  • WorkDay

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