team

Our professionals ar committed to pursuing excellence in the sevices provided.

Stéphane Gumy, CEO PM System S.a.r.l

GENERAL MANAGER / SENIOR CONSULTANT

Stéphane Gumy

Degree in chemistry (HES).
With over 18 years experience for pharma, biopharmaceutical & medical device industry in small and medium-sized entreprises (SMEs) as well as in international companies leading QA, QC, manufacturing and process development groups. Since 2007 independent consultant. Since 2013 Qualified Person.

  • Project management
  • Aspects related to the compliance
  • Risk analysis
  • Third party audit
  • Inter- or intra-company trainings
  • Equipment qualification and CSV
  • Media fill and process validation

Phone: +41 (0)79 512 43 16
E-mail: stephane.gumy@pmsystem.ch

Dr. Monika Bucher-Rager, Senior Consultant at PM System S.a.r.l.

senior pharma consultant

Dr. Monika Bucher-Rager

PhD in Virology (cloning, propagation and analysis of recombinant virus)​. 12 years of experience in biopharmaceutical industry in leading positions in the process development and production of parenterals as well as in the function of QA Compliance Manager.

  • Process design, scale-up
  • Process validation
  • Planning of GMP-compliant production facility
  • Cleanroom qualification
  • Aseptic processing
  • Deviation handling
  • Risk analysis
  • Audit

Phone: +41 (0)79 391 30 27
E-mail: monika.bucher@pmsystem.ch

Dr. Philippe Paroz

SENIOR PHARMA CONSULTANT

dr. philippe paroz

PhD in Microbiology​. 40 years of experience in biopharmaceutical industry in Top-Management positions,  such:

  • Member of the International Operation Committee in international biopharmaceutical company
  • Executive Vice-President in international biopharmaceutical company
  • Qualified Person
  • Member of Swiss gene therapy committee

Specialist for the following consulting activities:

  • Contracted Qualified Person
  • Vaccine industry
  • Aseptic processing
  • Training
  • Project Management
  • Audit

Phone: + 41 (0)79 334 73 59
E-mail: philippe.paroz@pmsystem.ch

Dr. Andrei Issakov, Senior Meddev Consultant and Business Development Manager at PM System S.a.r.l.

Senior Meddev Consultant & Business Development Manager

Dr. Andrei Issakov

MD, MPH, PhD Surgery.
40 years of experience in clinical practice and public health at national and international levels including 24 years in senior positions with the World Health Organization and 7 years as international consultant. Extensively worked with various stakeholders such as governments, international organizations, academic and research institutions, industry and civil society, and implemented numerous multidisciplinary international projects in some 135 countries.

  • International health networking
  • Stakeholder engagement and partnership building
  • Health systems and services organization and management
  • Healthcare quality and patient safety
  • Health technology assessment, planning and management with a special focus on medical devices.

Phone: +41 (0)79 757 86 31
E-mail: andrei.issakov@pmsystem.ch

manuela-straub

QA / Validation Specialist

Manuela Straub - Koller

Degree in chemistry (HES).
Over 10 years industrial experience in process technology and QA. Specialist for:

  • Quality assurance
  • Process technology
  • Equipment qualifications
  • Process validation

Phone: +41 (0)79 830 50 17
E-mail: manuela.straub@pmsystem.ch

Dr. Vitaliy Kolesov, Consultant for Life Sciences at PM System S.a.r.l.

Consultant life sciences

Dr. Vitaliy kolesov

PhD in Materials Science (Polymer Chemistry).

  • Quality assurance (GMP, ISO 13485)
  • CE-Mark
  • Cleanroom qualification
  • Equipment qualification
  • Cleaning validation
  • Gas production & distribution
  • Risk analysis
  • Calibration of T sensors / Thermomapping

Phone: +41 (0)78 873 12 71
E-mail: vitaliy.kolesov@pmsystem.ch

Susanne Zeltner

Life sciences Consultant

susanne zeltner

Bachelor in Biotechnology. 10 years of experience in biopharmaceutical industry in Top-Management positions, such:

  • Filling and Packaging processes of sterile and non-sterile products
  • Aseptic processing
  • Quality assurance
  • Risk management
  • Equipment qualification
  • Process and Cleaning validation

Phone: + 41 (0) 79 373 51 39
E-mail: susanne.zeltner@pmsystem.ch

Portrait Picture of Astrid Glück

Life Sciences Consultant

Dr. Astrid Glück

PhD in Cellular and Biomedical Sciences

  • Clinical Affairs
  • QA Affairs
  • Equipment Qualification
  • Sterile Manufacturing

Phone: +41 (0)79 413 02 04
E-mail: astrid.glueck@pmsystem.ch

Matthieu Gaillard

LIFE SCIENCES CONSULTANT

MATHIEU GAILLARD

Bachelor in Biotechnlogy

  • QA Affairs
  • Equipment Qualification
  • Computer System Validation
  • Biomanufacturing

Phone: +41(0) 79 638 014 57
E-mail: mathieu.gaillard @pmsystem.ch

Manuela Gumy, Account and Human Resources Manager at PM System S.a.r.l.

Account & HR Manager

Manuela Gumy - Blatter

Phone: +41 (0)76 337 03 34
E-mail: manuela.gumy@pmsystem.ch