team

Our professionals are committed to
pursuing excellence in the services 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. 10 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
  • Aseptic processing
  • Cell therapy
  • Risk analysis
  • Biosafety
  • Quality management

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. Ilia Leviev

SENIOR MEDTECH CONSULTANT

DR. ILIA LEVIEV

PhD in Biochemistry. More than 10 years of experience in medical device industry in leading positions as Regulatory Affairs Manager, Quality Affairs Manager and Project Manager.

  • Organizing the QMS for devices manufacturing
  • Regulatory support of Clinical Investigations (obtaining the authorizations, safety reporting)
  • Registration of Medical Devices in non-EU countries
  • Assembling the EU CE mark Technical Documentation
  • Design and review of labelling and patients’ information

Phone: +41 (0) 76 297 22 90
E-mail: ilia.leviev@pmsystem.ch

Patrick Buschor PhD

Consultant life sciences & Deputy General Manager

Dr. Patrick Buschor

PhD in Immunology. Five years of experience in biopharmaceutical industry in a leading role as Quality Assurance Manager for GMP certified manufacturing of parenteral drugs. Experienced in translational research and regulatory submissions.

  • Project and QA management
  • Sterile manufacturing
  • Regulatory/Medical affairs
  • Quality by design
  • Lean solutions for QMS
  • Process design, optimization and validation
  • Risk analysis

Phone: +41 (0) 79 712 55 90
E-mail: patrick.buschor@pmsystem.ch

Portrait Pragash Vijay PMS

MEDTECH CONSULTANT

PRAGASH VIJAY

Master in Biomedical Sciences

  • Regulatory Affairs
  • Quality Assurance
  • Quality Management System
  • Medical Devices: MDD & MDR
  • In-Vitro Diagnostic Devices: IVDD & IVDR

Phone: +41 (0) 78 892 62 49
E-mail: pragash.vijay@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

Mathieu Gaillard - Life Sciences Consultant

LIFE SCIENCES CONSULTANT

MATHIEU GAILLARD

Bachelor in Biotechnlogy

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

Phone: +41 (0) 79 638 14 57
E-mail: mathieu.gaillard @pmsystem.ch

Daniel Fallegger - Life Sciences Consultant

LIFE SCIENCES CONSULTANT

DANIEL FALLEGGER

Master in Biochemistry. Experience in pharmaceutical industry (production and process development) for parenteral drugs products. Experienced in clean room operations as well as process engineering.

  • Sterile manufacturing
  • Equipment Qualification and Validation (DQ/IQ/OQ/PQ)
  • Process Validation, e.g. Cleaning Validation
  • Pharmaceutical drug product production
  • Hygiene concept for clean room operations
  • Risk management
  • QMS Experience

Phone: +41 (0) 79 560 00 08 
E-mail: daniel.fallegger@pmsystem.ch

Muriel Soittas

LIFE SCIENCES CONSULTANT

MURIEL SOTTAS

Master in Life Sciences and Technologies

  • QA affairs
  • Equipment qualification
  • Biomanufacturing
  • Diagnostic activities

Phone : +41 (0)79 447 70 53
E-mail : muriel.sottas@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