Good Manufacturing Practice Experts in Switzerland
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Meet FRATCH Experts in Switzerland, who have recently used Good Manufacturing Practice
Vincent V.
Last position:
IT Business Partner & Enterprise Architect at Sulzer
- Established the Enterprise Architecture function from the ground up for Sulzer Group (~13,500 employees, CHF 3.6B revenue)
- Defined the Technical Governance framework, Target Operating Model, and IT PMO foundation now governing architecture decisions and portfolio demand across all divisions.
- Deployed SAP LeanIX as the authoritative application portfolio system of record - catalogued 500 applications group-wide (140 for Chemtech), onboarded business and IT stakeholders, and initiated integration with ServiceNow to embed architecture data into operational workflows.
- Led the divisional & group wide Application Rationalization initiative
- Decommissioned 15% of the 140 applications Chemtech portfolio, delivering CHF 627k in run-rate savings over two years and materially reducing licensing and support exposure.
- Defined and executed the divisional AI Roadmap in partnership with Sales, Legal, and R&D leadership
- Delivered 4 AI solutions into production (including Sales process harmonization and LLM-based IP conflict detection) from a portfolio of 7 prioritized initiatives.
- Built and owned the 3-year IT Strategic Roadmap for Chemtech
- Aligned cloud and technology architecture with divisional business priorities and a CHF 1.5M annual investment envelope.
- Delivered CHF 500k in cost avoidance by challenging and discontinuing funded but low-value initiatives, demonstrated governance discipline and executive influence, with zero implementation spend.
Sebastiano G.
Last position:
Interim Manager & Strategic Advisor | Organization, People, Process & Digitalization at Sebastiano Guzzanti Solutions
- Strategic consulting: End-to-end optimization of SCM, processes, and structures based on 30 years of industry experience.
- Interim management: Leadership responsibility to bridge vacancies and stabilize teams during transformations.
- Transformation & Assets: Support for restructurings, asset utilization & brokerage (surplus assets), and digitalization (SAP S/4HANA).
Veit M.
Last position:
Test Method Development and Validation Engineer at Gebr. Renggli AG
- Test method validation for destructive testing (peel-force testing) according to ASTM F88/F88M
Oliver W.
Last position:
Specialist Planner / Cleanroom Planning Lead at Major Aircraft Manufacturer
- Start-up and commissioning of the cleanroom
- Certification of the cleanroom
Elias V.
Last position:
Cloud Architect & Security Advisor at BaFin
- Designing hybrid cloud architectures (on-prem + cloud)
- Implementing cloud governance structures according to NIS2, BSI, ESCB/SMM
- Developing policies for cloud security & access control
- Target designs, management decision frameworks, internal audits & cloud integration
Olivia D.
Last position:
Founder – Pharmaceutical Quality and Compliance Consulting Services at Tulia Via GmbH
- Provide pharmaceutical quality and compliance consulting services to early-stage and growing biotech and pharmaceutical companies
- Support inspection and mock inspection readiness, licensing, and compliant global distribution
- Support setup and remediation of GMP and GDP compliant Quality Management Systems
- Provide transitional and fractional Responsible Person services (EU and FvP in CH) to ensure regulatory compliance and business continuity
Jürgen S.
Last position:
Manager Manufacturing Operations USP at Thermo Fisher Scientific
- Liquida, aseptic/sterile, fill & finish, solida in production & packaging
- CAPEX/Greenfield, 5kL SUT Owner, CVQ, runs/SCM/SCORE, SFM, KPI, CAD, CQV, MSAT, trainings, audits, EHS
- Organization, construction, sterile production, operations, packaging, PPQ, Op-readiness, RM, audits, documentation authoring
Hans S.
Last position:
Interim Manager, Consultant, Facilitator at Business Excellence Services GmbH
Interim manager, consultant, facilitator
Project management with focus on trouble shooting & customer care and/or product development/reengineering; regulatory management
Supply chain; risk and quality management; people management
Experienced within medical device; aerospace; packaging; small- & large equipment; optical- & electrical-systems; metal & plastics; free auditor
Since 2016, working for various accredited organizations as a freelance auditor regarding systems according to ISO 13485 and ISO 9001
2023-2024: Medical device product development, supply-chain and regulatory set-up with regard to a medical device re-engineering/launch and manufacturing
2023-2024: Project trouble shooter & customer care in the European aerospace industry within precision optics systems manufacturing; project risk and validation management including software validation
2022: Validation (FMEA, IQ OQ, PQ) management assigned with design and process risk assessment of complex electrical (IEC60601-1) mechatronics robots for MDR approval following ISO 14971
2022: Interim head of QM in aluminum-foil deep drawing process improvement; people and international Nespresso supplier quality management
2021-2022: Cytiva Cell Therapy greenfield project; assigned with design and implementation support of a certification, validation, GMP commissioning strategy for the technical infrastructure, e.g., clean rooms
2020-2021: Interim QA-Leader in Denmark assigned with the software release, manufacturing and distribution of Class IIb laser equipment for Candela, including international notified body and manufacturing transfer project
2020: Quality support and interim quality management for a manufacturer in the IVD test equipment supply chain and dialysis supplies in Bavaria
2018-2020: Expert/SME in Q-Management/Q-Engineering for orthopedic and arthroplasty device and tool production: turning, milling, cleaning, surface treatment and sterile packaging
2017: Re-engineering of the Medela product development process regarding cGMP 21CFR820.30/ISO 13485:2016 and MDR design control requirements for soft and hardware design regarding Class IIb pumps
2017: MDSAP preparation support and mock-audit coaching
2016: Interim senior QE-Expert for Maquet extracorporeal circulation devices manufacturing as ISO 14971 risk and change management expert in a Roche CAPA remediation and compliance project of IVD blood analyzers/gas sensor production
2016-2017: Orthopedic and arthroplasty implants design history file (DHF) review regarding compliance to 21 CFR 820.30 design control requirements
2015: Assigned by Novartis with design control for a new parenteral drug delivery system; manufacturability assessments during design evaluation; assessing potential plastic injection molding and/or high-volume assembly contractors in Europe and the US
2014: Assessing/auditing metallurgy process validation (IQ/OQ/PQ) of Zimmer contract manufacturers around Europe for FDA audit readiness; Depuy-Synthes subject matter expert (SME)
2013-2014: CAPA-8D process reengineering and setting in place/training new EtQ software tools; coaching of project and product managers in working through individual CAPAs; remediation of global legacy CAPAs; supporting complaint and field action (FSCA) management
2012-2013: QA/RA Manager at Sias AG for in vitro diagnostics (IVD) liquid handling robots manufacturing; led small team for electrical safety CE/CB scheme product approvals; QMS, change and CAPA management
2011-2012: Site Quality Manager at Medtronic for drug eluting balloon and Nitinol stent-catheter manufacturing; quality operations including Q-engineering and control; led 15 direct and indirect reports
2009-2010: Supported quality initiatives in medical device industry; assessments and audits for manufacturers and suppliers as a consultant of Business Excellence Services
Klaus F.
Last position:
Freelancer at 3P Quality Consulting
Data integrity training (basic and advanced training content)
Root cause analysis and CAPA courses for 40+ employees
Risk-Management system design for quality oversight
SOP writing excellence, including use of AI tools (prompting)
Implementation of an audit remediation program as person in the plant (PIP)
Director of a quality assurance department (6 direct reports), budgeting
Development of use cases for ChatGPT in GxP context (6 months, part-time)
Reengineering of processes for a MA holder of generic products, valued operational improvements (Germany, Spain)
eQMS and document management system: delivery of the business case and investment recommendation
Analytical method validation, process and computer system validations, batch record review, PQR reviews
Articles in international journals and LinkedIn on modular QMS-design, risk-management in the supply chain, knowledge management, use of AI for compliance improvements
Andrew L.
Last position:
Service Manager - Testing at Takeda Pharmaceutical International AG
- Managing the Testing services for the Global IT Testing Centre of Excellence (TCoE) team, which is responsible for managing and supporting the Product & Project Testing Workstreams on various Regional Projects, especially in Pharmacovigilance, Digital Supply Chain, Clinical Practice and R&D, etc.
- Managing Client relationships, escalations and continuing to grow the project services globally, while also driving the testing efforts on Takeda’s AI, DevOps, Agile, and Digital projects.
- Led the implementation of a Quality Management System (QMS), ensuring compliance with GCP, GMP, and Swiss and EU regulations, resulting in a huge improvement in audit readiness.
- Overseeing projects for systems including ERP, EDGE, SAP ECC, SAP Transportation Management, S/4 HANA migration etc.
- Led an AI/ML PoC for AI implementation.
- Led a cross-functional team to ensure compliance with MDR, FDA regulatory guidelines and achieved successful project deliveries.
- Led and managed change management and communication for TCoE, keeping the Takeda organisation informed of change communication and practices, including presentations to various stakeholders.
- Ensuring TCoE outsource vendor resources adhere to regulatory, compliance and quality system standards and practices for GxP & non-GxP System Development Life Cycle (SDLC) including aSDLC and TCoE Global Standards.
- Translated the product vision, strategy and requirements into backlog items, which were prioritised based on potential business impact and customer value.
Antonis V.
Last position:
Security and Audit Consultant at Contractor
Consulting on Cyber Security, Governance, Risk Management, audits, Cloud Security, and compliance in regulated environments.
Holger L.
Last position:
Regulatory Affairs Manager at Andreas Hettich GmbH
Martin A.
Last position:
Martin Aicher
Main areas of activity ⋅ Martin Aicher
Areas of expertise
Medical technology
Sensor technology
Technical optics
Mechatronics
Microsystems technology
Biocompatible materials
Implants and endoprosthetics
Project management
Quality management IPMA
Regulatory affairs
Education
Dr.-Ing. Medical Technology
M.Sc. Medical Technology
Dipl. Ing. (FH) Medical Technology
Surgical mechanic, precision mechanic
Methodical product development
26 years of research, development, verification and agile product development
5 years of hands-on manufacturing of micromechanical instruments and implants
Projects
Development and verification of technical optics
Microscopy
Endoscopy
Immersion optical systems
Optical sensors
Light guides
Device development — medical electronics, active medical devices
Electromagnetic therapy devices for microcirculation of blood vessels
Electric drives, precision mechanics motors
Embedded devices, Medicine 4.0 / Industry 4.0
Feasibility studies, prototype design, electromechanical, chemical and hydrodynamic characterization up to series maturity
Structural integration of motors for pump systems
Integration of motors for catheter drives
Implantable drive systems with motors
Bone saws with Maxon motors
Osteosynthesis implant (bone implant) with linear drive
Electromagnetic therapy devices for microcirculation of blood vessels
Gold and platinum substitution for electrodes
Electrochemical impedance spectroscopy (EIS)
Characterization and development of battery cells and Li-ion batteries
Biocompatible materials: stainless steel, titanium, nitinol, polymers, ceramics, composites
Vacuum device with pumps for wound healing
Braided tubes (reinforced hoses)
Shaft instruments and trocars
Surgical instruments, minimally invasive instruments (MIC)
Analytical instruments, sensors and fluid preparation
Monitoring systems
In vivo diagnostics (IVD)
Inline measurement systems for monitoring and analytical devices
Feasibility studies, prototype design, electrochemical and hydrodynamic characterization up to series maturity
Electrochemical deionization (EDI) as a monitor
Membrane technology
Measurement method and control of carbide saturation in cooling water
pH sensor
Optical sensors with laser diodes and LEDs
Dissolved O2 sensor
CO2 sensors
Ion-selective sensor (ISE)
Conductivity sensors
Turbidity sensor according to ISO 7027
Biosensors
Flow and pressure sensors
Gold and platinum substitution for electrodes
Electrochemical impedance spectroscopy (EIS)
Biocompatible materials: stainless steel, titanium, nitinol, polymers, ceramics, composites
Design of plastic injection-molded components and housings
Calculation and design of fluid channels
Design of metal die-cast components
Design of sheet metal parts
Implants and prostheses
Endoprosthetics: knee and hip endoprostheses
Bypass implants
Nitinol stents
Bone plates
Dental implants
Precision meshes
Instruments for medical technology
Angioplasty: PTCA percutaneous transluminal coronary angioplasty with balloon catheter
Catheter system as minimally invasive heart pump
EN ISO 10555-4: intravascular catheters
Braided tubes (reinforced hoses through precision meshes)
Thrombectomy with rotablation catheter
Trocars
Surgical instruments, minimally invasive instruments (MIC)
Endoscopes ISO 8600-1, EN 60601-2-18, EN 62471
Regulatory affairs for medical devices
CE for Europe (Class II and III), EU Medical Device Regulation 2017/745 (MDR)
EU Regulation 2017/746 for in vitro diagnostics (IVDR)
Ensuring complete documentation according to current regulatory requirements
FDA registration and approval 510(k), PMN, PMA, Class II, III
Design History Files (DHF), Device Master Record (DMR), Device History Record (DHR)
Internal and external audits
FDA and CE audits
Mock audits
Requirement engineering, user requirement specifications, functional requirement specifications
Quality management and relevant standards for medical technology
EN ISO 9001:2015
EN ISO 13485:2021
USA FDA 21 CFR 820 Quality Management System
FDA 21 CFR §§ 803, 806, 807, 830
In vitro diagnostics (IVD, IVDR) FDA 21 CFR §§ 600, 610, 660
USA FDA risk management for medical devices DIN EN ISO 14971:2019
P-FMEA for production
Usability of medical devices EN 62366-1:2021
CAPA (Corrective and preventive action) and GMP
Medical electrical equipment EN 60601-1:2013
EMC for medical devices DIN EN 60601-1-2:2022
Medical device software EN 62304:2018
Cell culture in cleanroom with different cell lines for biocompatibility testing of polymers and alloys
Biological evaluation of medical devices EN ISO 10993
Clinical investigation of medical devices ISO 14155
Manufacturing technology and processes
Process qualification and validation
Injection molding technology
CNC micromechanical manufacturing
Microsystems technology, printed circuit boards (PCB)
Joining technologies: laser welding of titanium, stainless steel, plastics as well as gluing and ultrasonic welding
Evaluation, setup and qualification of equipment
Thin film and surface technology
Coating of implants and tribological surfaces with chemical vapor deposition (CVD) and physical vapor deposition (PVD), sputtering of precious metals, stainless steels, nitinol, titanium alloys, polymers and ceramics
Plasma technology for functional coatings: hydrophilic and hydrophobic surfaces
Nanotechnology: surface functionalization: self-assembled monolayers (SAM)
Product Life Cycle Management
Finite element method
ANSYS FEM
Structural mechanics, statics
Fluid mechanics, flow simulations
Electrical engineering, electromagnetic fields
Characterization and testing of microelectronics
PCB (printed circuit board)
Sensor technology
Microcontrollers
CAN bus: ISO 11898, SAE
Control and data management with LabVIEW and Matlab
Programming language
Python 3.14
CAD
Autodesk Inventor
Pro/ENGINEER, PTC Creo Parametric
SolidWorks
Siemens NX
Solid Edge
Standards-compliant technical drawings
Endurance tests, mechanical, fluid mechanical, electrical and chemical characterization
Verification, V-Model, End of Line (EOL) testing
Writing work instructions for production, English regulatory documents and scientific articles
Support of clinical studies
Data processing, digital data management and statistics
Professional handling of Microsoft Office applications: PowerPoint, Word and macro programming for Excel
© 2026 M. Aicher
Thomas H.
Last position:
Sales Partner at SourceWeb Group
- Consulting and sales in cyber security
Axel K.
Last position:
Project Manager and Owner's Representative in Technical Trades at Carl Zeiss AG
- New factory buildings, ISO5 cleanroom
- Oberkochen
- Construction cost EUR 1.2 billion
Discover over 15,000 top freelancers
Statistics of experts using Good Manufacturing Practice
Aggregated from the professional profiles of matched freelancers.
Experience
29 years
Position duration
3.2 years
Positions per freelancer
11
Top business areas
Project Management, Quality Assurance, Information Technology
Top industries
Pharmaceutical, Healthcare, Manufacturing
Certification focus areas
Quality Assurance, Information Technology, Audit
Bachelor's degree or higher
92%
Master's degree or higher
77%
Doctorate
46%
Certifications per freelancer
4
Most common languages
English, German, French
Speak two or more languages
100%
Based on our profile pool as of 19 Sep 2026.
Daily rate distribution
The chart shows how the daily rates of freelancers in this technology in Switzerland are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows how many freelancers charge within that range.
Average rates of experts in Switzerland using Good Manufacturing Practice
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 19 Sep 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
Good Manufacturing Practice experts industry focus
See which industries our matched freelancers work in most often — every figure is calculated live from the freelancers on FRATCH.
- Pharmaceutical (81%)
- Healthcare (63%)
- Manufacturing (63%)
- Biotechnology (44%)
- Banking and Finance (38%)
- Information Technology (31%)
- Aerospace and Defense (25%)
- Insurance (19%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
Quality assurance frameworks in regulated production
Good Manufacturing Practice ensures products are consistently manufactured and controlled according to stringent quality standards. It minimizes risks inherent in pharmaceutical and medical device production, including cross-contamination, labelling errors, and unexpected adulteration. These guidelines safeguard consumer safety and maintain therapeutic efficacy across batch lifecycles.
Core standards and compliance ecosystems
The GMP framework intersects with multiple regional and international standards that govern manufacturing environments:
- Annex 1 sterile manufacturing regulations and aseptic processing protocols
- Swissmedic guidelines, EU GMP Volume 4, and FDA 21 CFR Part 210/211
- Good Automated Manufacturing Practice standards for computerized system validation
- Data integrity frameworks adhering to ALCOA+ standards
- ISO 13485 quality systems alongside Current Good Manufacturing Practice
When enterprises require specialized external support
Organizations engage external specialists during facility commissioning, critical technology transfers, or impending health authority audits. Independent expertise resolves compliance bottlenecks quickly during remediation programs, process validations, or the implementation of digital quality management systems across production facilities.
Critical competencies in quality infrastructure
Senior professionals bring hands-on experience in equipment qualification, analytical method validation, and risk management using FMEA methodologies. They design robust standard operating procedures, execute thorough deviation investigations, and establish corrective and preventive action systems that satisfy inspectorates like Swissmedic and the FDA.
Project execution and delivery formats
Work typically takes place through hybrid arrangements. Documentation design, validation master plans, and risk assessments progress effectively off-site. Conversely, physical facility qualifications, on-the-floor batch record reviews, mock audits, and operator training sessions require dedicated on-site presence directly on the manufacturing floor.
Operational indicators of elite expertise
Top specialists combine deep scientific understanding with practical operational insight. They avoid theoretical paper compliance, designing lean quality processes that protect product integrity without impeding operational throughput. Their track record reflects successful regulatory inspections, audit closures, and defensible technical documentation.
Frequently asked questions
Everything clients usually want to know about Good Manufacturing Practice, in one place.
Good Manufacturing Practice covers all aspects of production from starting materials, premises, and equipment to personnel training and personal hygiene. Detailed, written procedures are indispensable for each process that could influence the final quality of the finished batch. The framework ensures that systems document every step to prove consistent compliance.
While GMP governs commercial manufacturing, batch release, and packaging safety, GLP regulates non-clinical laboratory safety studies, and GCP oversees clinical trials involving human subjects. All three form the overarching GxP quality umbrella, but each targets a distinct stage of the life sciences development continuum.
Strong practitioners often hold expertise in computerized system validation, statistical process control, cleanroom microbiology, and root cause analysis tools like Ishikawa diagrams. Familiarity with electronic batch records and manufacturing execution systems complements Current Good Manufacturing Practice execution.
Autonomous leadership on validation projects, facility design reviews, or Swissmedic preparation requires solid career exposure across regulated manufacturing. Complex remediation programs demand specialists who have successfully navigated multiple health authority audits under cGAP or international quality systems.
While drafting quality documentation and reviewing analytical data can occur remotely, critical phases of Good Manufacturing Practice projects require on-site intervention. Physical walk-throughs, facility walkthroughs, equipment installation qualification, and mock inspections are most effective directly on the production floor in Switzerland.
English is standard for global regulatory files and tech transfer documents, but Swiss manufacturing facilities frequently use German or French on the plant floor. A specialist in GMP who communicates fluently in local plant languages conducts operator training and deviation interviews with substantially greater clarity.
Teams often apply a blanket compliance approach instead of using risk-based qualification under GAMP 5. This results in excessive validation documentation for low-risk automation while critical data integrity interfaces receive insufficient scrutiny. Experienced specialists align validation efforts with patient safety and product quality risks.
Evaluate their direct exposure to regulatory inspections by bodies such as Swissmedic, the EMA, or the FDA. Strong Good Manufacturing Practice professionals discuss real-world deviation management and demonstrate how their validation strategies prevented compliance findings while supporting manufacturing efficiency.
The average hourly rate of freelancers in Switzerland who have used Good Manufacturing Practice in their recent projects is 140 €, which corresponds to a daily rate of about 1,122 € based on an 8-hour working day.
Of the freelancers in Switzerland who have used Good Manufacturing Practice in their recent projects, 92% hold at least a Bachelor's degree, 77% hold at least a Master's degree, and 46% hold a doctorate.
On average, freelancers in Switzerland who have used Good Manufacturing Practice in their recent projects have 29 years of professional experience, with a single engagement typically lasting around 3.2 years.
The most common languages among freelancers in Switzerland who have used Good Manufacturing Practice in their recent projects are English (100%), German (94%), and French (38%).
The most common industries among freelancers in Switzerland who have used Good Manufacturing Practice in their recent projects are Pharmaceutical (81%), Healthcare (63%), and Manufacturing (63%).
The most common business areas among freelancers in Switzerland who have used Good Manufacturing Practice in their recent projects are Project Management (81%), Quality Assurance (69%), and Information Technology (56%).
Main locations of FRATCH Experts, who have recently used Good Manufacturing Practice
Our freelancers and interim experts are at home across the DACH region — available on-site in the major business hubs or fully remote. Choose a location to discover matched specialists, local market insights and up-to-date availability.
Zurich Request a free demo
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Philipp Thomaschewski
FRATCH CEO
