The MGP Consulting Team
Marcel Goverde
Professional experience
- Release analyses for sterile and non-sterile drug products, excipients and active pharmaceutical ingredients
- Development of methods, qualification, validation
- Microbiological monitoring and data trending
- Growth promotion testing of culture media
- Container-closure integrity testing
- Examination of disinfectants and their efficiency
- Antimicrobial effectiveness testing
- Bioindicators for the validation of aseptic processes or decontamination purposes
- Validation of rapid or alternative microbiological methods
- Risk assessment, deviations, microbiological support
- Training sessions
- GMP and microbiological audits
- Lean Labor and Six Sigma- Interdisciplinary projects
Professional background:
Since 2011
Marcel Goverde has led his own company that specializes in training, consulting and project management in GMP-relevant areas with a focus on microbiology, hygiene and deviation management
2021 - 2022
Microbiological operations manager at a start-up company
2010 – 2011
QC Expert Microbiology, QA/QC Biological & Microbiological Services, ChemOps, Novartis Pharma AG, Basle, Switzerland Main tasks: drug substance release testing, antimicrobial effectiveness testing, risk assessments, deviation handling, LEAN lab, microbiological support
2002 - 2010
Team leader Non-Sterile Products, QC Microbiology, at F. Hoffmann - La Roche Ltd., Basle, Switzerland. Main tasks: product-release testing, microbiological support and monitoring, method development, qualification and validation, projects
Since 2004
Regular speaker for different institutions
Since 2003
Swiss delegate for working group 1 at the EDQM (European Directorate for the Quality of Medicines and Health Care), Strasbourg, France
1994 - 2000
Scientific collaborator at Hintermann & Weber AG, Switzerland, Post Doc and lecturer at the University of Basel. Practical training in the agro biological section of Novartis, Pro Natura and Longo Maï (Costa Rica). Teaching experience at the secondary school level, Switzerland
Languages:
German
Mother tongue
English
Fluent, very good writing skills
French
Fluent, good writing skills (second mother tongue)
Spanish
Working knowledge
Dutch
Fluent (third mother tongue)
Eminé Floret
Professional experience
- More than 10 years of experience in microbiological quality control and laboratory management.
- Expertise in microbiological testing of non-sterile products including TAMC, TYMC and specified microorganisms as well as water samples and in-process controls (IPC).
- Expertise in particle and microbiology monitoring, including trending
- Specialised in growth promotion testing of culture media and primary packaging integrity testing.
- Evaluation of disinfectants and their efficacy in controlled environments.
- Expertise in the use of bioindicators for aseptic process validation and decontamination studies.
- Development and validation of sterilisation processes and analytical methods.
- Extensive experience in the qualification and validation of laboratory equipment.
- Computer System Validation (CSV) for laboratory systems.
- Creation and implementation of Standard Operating Procedures (SOPs) for microbiological processes.
- Active participation in regulatory inspections and audits to ensure compliance with industry standards.
- Conduct risk assessments and manage deviations while providing microbiological support.
- Conduct training on microbiological testing and quality standards.
- Contributing to Lean Lab and Six Sigma projects to drive process improvements.
Professional background:
Since May 2024
Senior Project Manager, specialised in training, consulting and project management in GMP-relevant areas with a focus on microbiology, quality assurance and risk management.
2021 - 2024
Senior Scientific Associate at a start-up pharmaceutical company. Main tasks: Setting up laboratories for microbiological quality control, developing standard operating procedures (SOPs), performing equipment qualification, providing microbiological expertise for sterile production and assisting with regulatory inspections and compliance.
2021
Laboratory specialist in the field of medical devices. Main tasks: microbiological testing, validation of sterilisation processes and management of regulatory documentation.
2017 - 2021
Laboratory technician in a quality control laboratory for healthcare products. Main tasks: Management of a microbiological team, review of analytical results, participation in audits and implementation of continuous improvement projects (Greenbelt certified).
2015 - 2017
Laboratory technician for microbiological quality control. Main tasks: Environmental monitoring, microbiological analysis, initiating deviations and process optimisation.
2015
Laboratory technician in food quality control. Main tasks: Carrying out microbiological analyses of food samples and compliance with quality standards.
Languages:
French
Mother tongue
Turkish
Second mother tongue
English
Very good oral and very good written skills
German
Good oral and written skills
Samira Giger
Professional and academic background:
Since 2024
Administrative and research assistant at GMP Consulting
Since 2022
Bachelor of Pharmaceutical Sciences University of Basel
2022 - 2023
Administrative employee at the University Hospital Basel
2020 - 2022
Branch employee, Lidl Switzerland AG
Languages:
German
Mother tongue
Spanish
Mother tongue
English
Oral and written skills
French
Oral and written knowledge
Sabrina Kuoni
Professional and academic background:
Since 2022
PhD student at the research department of obstetrics at University Hospital Zurich
2021 - 2022
Pharmacist in a public pharmacy. Main tasks: Counselling and support, dispensing of prescription and over-the-counter medicines, preparation and testing of prescriptions and defectives, account management and ensuring drug safety.
2021
State examination - Swiss certified pharmacist
2016 - 2021
Bachelor and Master in Pharmacceutical Sciences, University Basel
Since 2014
Administrative employee at MGP Consulting GmbH
Languages:
German
Mother tongue
English
Very good speaking and good writing skills
French
Good speaking and writing skills
Dutch
Speaking skills
