team
Our professionals are committed to
pursuing excellence in the services provided.
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
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
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
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
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
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
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
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
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
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
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
Account & HR Manager
Manuela Gumy - Blatter
Phone: +41 (0)76 337 03 34
E-mail: manuela.gumy@pmsystem.ch