team
Our professionals ar committed to pursuing excellence in the sevices 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 (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
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
junior pharma consultant
Joël roeske
Bachelor of Science in Chemistry (HES).
- Analytical Chemistry
- Process engineering
- Risk Analysis
- Method Validation
- ISO 17025:2015
Phone: +41 (0)79 607 08 53
E-mail: joel.roeske@pmsystem.ch
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
Life Sciences Consultant
Astrid Glück
PhD in Cellular and Biomedical Sciences
- Clinical Affairs
- Equipment Qualification
- Sterile Manufacturing
Phone: +41 (0)79 413 02 04
E-mail: astrid.glueck@pmsystem.ch
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
Account & HR Manager
Manuela Gumy - Blatter
Phone: +41 (0)76 337 03 34
E-mail: manuela.gumy@pmsystem.ch