GAMP 5 Experts in Germany
in minutes from over 15,000 CVs with the power of AI.Hire experts who know GAMP 5 validation, risk-based documentation, CSV, and audit-ready change control for regulated systems, with fast, precise matching to vetted, available freelancers.
Meet FRATCH Experts in Germany, who have recently used GAMP 5
Florian Ripper
Last position:
Global Programme Lead, Ecosystem Separation at Merck Group
Electronics – Surface Solutions | Carve-out of IT, data and system landscape*
Separation of a full business division's IT, data and system landscape following divestment; centrally governed investment envelope in the three-digit m€ range
Laboratory notebook and laboratory analytics platform stream: Palantir Foundry, Snowflake, Signals Notebook, Power BI and connected laboratory instrumentation; site transition completed without interruption to laboratory operations
Decision authority and escalation point for business, IT infrastructure, IT security and vendors; separation executed across globally distributed users and systems, handed over on schedule
Michael Sartori
Last position:
IT & Test Consultant at Testing Experts GmbH
AI Readiness - Part 3: Creating an E-Book on the Use of AI in Software Testing
- Designing and creating an e-book on the meaningful and safe use of AI in software testing from the perspective of an experienced test expert.
- Using generative AI (ChatGPT, Perplexity Pro) as a sparring partner for structuring, wording suggestions and variant creation, with final technical review and approval of all content based on my own expertise.
- Developing practical opportunities and risks of AI in testing, with a special focus on collaboration between testers and AI instead of "tester vs. AI".
- Title: "11 Strong Reasons: Dream Team Instead of Rivals - Testers and AI Are Unbeatable Together"
- Subtitle: "How humans and machines form the perfect team in software testing—and why pure AI testing is risky."
- Planned use of the e-book as a basis for workshops, client presentations, or internal training.
- Technology: Generative AI, ChatGPT, Perplexity Pro, Microsoft Word, Adobe Acrobat, many years of professional testing experience, common sense.
Wolfgang Steiner
Last position:
Software Developer / Aviation Commissioning Engineer at Vakuum Schmelze Hanau
- Development of automation software and commissioning of a pneumatic press for processing electrical sheet stator cores, including KUKA robot handling, process monitoring, and connected measurement systems for quality inspection and sorting.
Dennis Dauscher
Last position:
Business Analyst (Delivery Governance) at Merck
- Drove governance routines (scope, milestones, status/risk tracking), scope and milestone planning for a global RIM reporting initiative based on Veeva Vault RIM data; worked with a cross-functional team (Regulatory, Safety, IT, BI).
- Designed and implemented integrated dashboards (e.g., first/last batch timelines, 180-day tracking, submission vs. approval); coordinated internal IT and external partners including backlog/release planning and cutover preparation.
Gunnar Wulf
Last position:
IT-Consultant at Independent Freelancer
- Enterprise and IT strategy
- Digital transformation
- Process and portfolio management
- Interim IT management
Thomas Arends
Last position:
Interim Management at Vincorion Power Systems GmbH
- Process and project management to optimize products and development processes for energy systems
- Technical risk management
- Requirements engineering and system architecture
- System FMEA of power generator units and energy storage modules aiming for generic structures
- Claims management according to Section 313 of the German Civil Code
- Regulatory environment: military and NATO standards, AQAP, VG norms
Kaliyan Muthukrishnan
Last position:
Techno-Functional Consultant – Digital Lab & Manufacturing Systems at Dynavax Technologies
- Led SampleManager LIMS 21.x & LabWare LIMS v8 implementation, reducing manual lab errors by 40% and improving data traceability.
- Configured LW LIMS & SM LIMS 21.2: workflow design, role-based access control (RBAC), and master data management.
- Designed and configured LES workflows: sample lifecycle management, test assignments, approvals, and result review processes.
- Managed Master Menu and CI configuration, ensuring consistency, data integrity, and regulatory compliance.
- Integrated LIMS 21.2 with MES, ERP, EM, WinKQCL (Lonza MODA), SoftMax Pro, Empower, and Chromeleon CDS via REST APIs and web services.
- Implemented PAS-X MES: architecture design, multi-platform implementation (PAS-X, Siemens Opcenter), and integration with PLC, SCADA, and DCS systems.
- Executed IQ/OQ/PQ qualification protocols and Validation Summary Reports (VSR) for QC analytical and utility systems in aseptic and sterile production environments.
- Developed and reviewed Risk Assessments, Traceability Matrices, and Data Integrity evaluations in accordance with ALCOA+, 21 CFR Part 11, and EU Annex 11.
- Led EMA/FDA/WHO inspection readiness, standardized CQV SOPs, enabled digital CQV integration (LIMS/CDS/MES/SCADA/ERP/SDMS), and ensured 21 CFR Part 11 & Annex 11 compliance.
- Managed secure OT cybersecurity: network configuration and access control.
- Configured NuGenesis SDMS for document/data management, CDS/LIMS integration, workflow automation, and reporting.
Daniel Christoph
Last position:
AI Engineer at EMLI GmbH
- Development and deployment of AI/ML models to support research, production, and QC processes in GxP-regulated life science environments
- Building scalable MLOps infrastructures for the production use of AI solutions in regulated areas, including cloud architectures and data pipelines
- Regulatory compliance and validation according to GAMP 5, EU AI Act, and data integrity requirements, including audit trail-compliant documentation
- Interdisciplinary project management in AI and digitalization projects: coordinating stakeholders, budget responsibility, client communication
- Data engineering and integration: analyzing diverse production data, ensuring data quality, and integration into validated systems
Michael Berger
Last position:
Program and Project Manager at Independent
- Project management: rollout, migration and implementation of international IT projects
- Sales and business development
- Finance and team management (up to 24 senior consultants) and stakeholder management (including executive level)
- Projects include diverse SAP ERP; SAP S/4HANA; cloud/on-premise, AI, machine learning
- Responsible for project computerized system validation (CSV), QA, project quality
- Implementation of CSV, QA in the project
- Key account management; responsible for all client projects and offerings
- Development of RFIs and RFPs
Vishal Vekariya
Last position:
GMP Referent in Quality Assurance - Validation Group at Menarini Von Heyden GmbH
- Working as a CSV (Computer System Validation) Engineer in QA
- Primary focus on corporate project: implementation of the manufacturing execution system (MES)
- Assisted in the planning and coordination of multiple sub-projects, maintaining project documentation
- Adept validation life cycle according to GAMP 5 (URS-FS-DS-FAT-SAT-IQ-OQ-PQ) to ensure compliance with regulatory standards
- Reviewed and approved master batch record (MBR) validation reports
- Monitored project performance against KPIs, ensuring continuous alignment with business goals and project scopes
- Managed the validation and integration of the SAP-MES interface, demonstrating a strong command of computer system validation (CSV) principles
- Experienced with quality management systems, for instance TrackWise
- Facilitated daily cross-departmental communication and alignment with external suppliers to ensure project milestones are met on schedule
Arno Klein
Last position:
Digital Project Management & Agile Consulting at Arno Klein Digital Projects & Agile Leadership
Ashwini Reddy Kapu
Last position:
Technical Analyst at GlaxoSmithKline
- Perform validation or qualification tests on new or existing processes, IT modules, equipment, Clinical trial software in compliance with internal norms or external standards.
- Resourceful in reviewing various documents, including VMP, URS, System Requirement Specification (SRS) and/or Functional/Technical Specification, Design Qualification (DQ), Risk Assessment (RA) with ALCOA CCEA, IQ, OQ, PQ, Traceability Matrix (TM), Compliance Report (CR), and Validation Summary Report (VSR), in accordance with regulatory requirements and quality management systems.
- Perform testing activities with Microfocus ALM and handle faults and deviations.
- Familiar with regulatory standards (such as FDA/GxP, records management, and disaster recovery).
- Proven expertise in risk management, FMEA, audit management, and periodic compliance reviews.
- Proficiency in change management and control procedures, deviation management, incident management, and CAPA escalation.
- Implementing a Quality System to meet GxP standards and ensure regulatory compliance through inspections, data review, and training.
- Conduct internal audits on processes and systems, prepare for external audits, and verify compliance with internal standards and SOPs.
- Develop and review SOPs and papers in accordance with regulatory norms.
- Organized and reviewed cGMP training records.
Amara El Madak
Last position:
Qualification Engineer at Optima Pharma GmbH
- Qualification of filling lines
- Preparation of IQ, OQ, PQ documents and reports
- Execution of FAT and SAT
- Alarm lists: create and perform tests
- Preparation of GMP-compliant documentation (qualification plan, URS, risk analysis, IQ, OQ, PQ and qualification report)
Franz Hamberger
Last position:
Software Developer at Roche Diagnostics GmbH
- Implementing microservices in C# using dapr and Docker for a system to exchange analysis requests and results between laboratory systems
- Implementing a test automation framework with C# and SpecFlow for this system
- Build and release management with GitLab
- Evaluating laboratory systems for extensibility (using Python) and integration
Rudi Salm
Last position:
Short Course in Compliance at FernUni Hagen
- University short course in compliance
Discover over 15,000 top freelancers
Statistics of experts using GAMP 5
Aggregated from the professional profiles of matched freelancers.
Experience
23 years
Position duration
2.2 years
Positions per freelancer
15
Top business areas
Quality Assurance, Information Technology, Project Management
Top industries
Pharmaceutical, Information Technology, Manufacturing
Certification focus areas
Information Technology, Quality Assurance, Project Management
Bachelor's degree or higher
86%
Master's degree or higher
64%
Doctorate
7%
Certifications per freelancer
3
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 30 Aug 2026.
Daily rate distribution
The chart shows how the daily rates of freelancers in this technology in Germany 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 Germany using GAMP 5
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 30 Aug 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
About the technology
What GAMP 5 means
GAMP 5, short for Good Automated Manufacturing Practice, is a practical guide for automating regulated work. It helps teams define what a system must do, how to test it, and how to keep evidence ready for review. Companies use it to support compliant software, equipment, and data flows.
Where it is used
It appears in pharma, biotech, medical device, and other regulated environments where control matters. It is common around MES, LIMS, SCADA, ERP links, and lab or production systems that must be validated and kept in a known state.
What specialists deliver
- Validation plans and test strategy
- URS, risk assessments, traceability, and review packs
- CSV support for software and infrastructure changes
- SOPs, training notes, and audit response material
Core skills around it
Strong professionals know the GAMP 5 lifecycle and the difference between intended use, risk, and evidence. They work comfortably with CSV, data integrity, Annex 11 expectations, and controlled change management. In Germany, they often need to align with English documentation and local quality teams.
When companies bring in help
Teams usually need outside support when a system is new, a legacy setup needs revalidation, or an audit raises gaps in documentation. Freelancers also help when internal quality teams are overloaded or when a project needs short, focused support across IT, operations, and QA.
What good work looks like
A strong GAMP 5 expert writes clear documents, asks precise questions, and keeps scope realistic. They know how to separate business need from regulatory proof and how to make evidence easy to follow.
- Clear, testable requirements
- Risk-based decisions that make sense
- Traceable evidence from start to finish
- Practical collaboration with QA, IT, and operations
Frequently asked questions
Need clarity? These are the questions we hear most often about GAMP 5.
GAMP 5 is used to control computerised systems that support regulated work, especially where documentation and testing must be defensible. It helps teams define requirements, assess risk, and keep validation evidence organized for review. That makes it relevant for software, lab systems, automation, and connected production tools.
GAMP 5 is the guidance many teams use to structure computer system validation, while CSV is the broader practice of validating a computerised system. Annex 11 is a regulatory expectation for computerized systems in GxP environments. In practice, strong specialists know how these pieces fit together and turn them into one coherent validation approach.
A good GAMP 5 specialist usually brings quality and validation skills, not just document writing. Useful adjacent experience includes CSV, risk assessment, data integrity, change control, audit preparation, and familiarity with systems like MES, LIMS, or ERP integrations. They should also communicate well with QA, IT, and operations.
A GAMP 5 project can range from a single document review to full validation support for a new system or major change. Smaller tasks may only need a specialist who knows the framework and can clean up gaps quickly. Larger programs need someone who can guide requirements, testing, and approvals across multiple teams.
Much of the GAMP 5 work can be done remotely, especially document drafting, review, planning, and gap analysis. On-site time becomes useful when a system sits in a plant, a lab, or a controlled production area and the specialist needs to observe real workflows. In Germany, many teams mix both depending on the project phase.
A strong GAMP 5 specialist produces documents that are clear, consistent, and linked back to risk and intended use. They do not overcomplicate the work, and they avoid generic templates that do not fit the system. Good signs are precise questions, clean traceability, and practical answers to audit comments.
No, GAMP 5 is most common in pharma, but it also shows up in biotech, medical device, and other regulated environments. Any company that needs controlled system behavior, traceable evidence, and audit-ready documentation can benefit from it. The exact depth of the work depends on the product, process, and risk.
Ask the GAMP 5 expert which systems they have validated, how they handle risk-based testing, and how they work with QA and business owners. It also helps to ask how they document change control, handle deviations, and prepare for audits. Those answers show whether they can fit your process, not just the template.
The average hourly rate of freelancers in Germany who have used GAMP 5 in their recent projects is 105 €, which corresponds to a daily rate of about 839 € based on an 8-hour working day.
Of the freelancers in Germany who have used GAMP 5 in their recent projects, 86% hold at least a Bachelor's degree, 64% hold at least a Master's degree, and 7% hold a doctorate.
On average, freelancers in Germany who have used GAMP 5 in their recent projects have 23 years of professional experience, with a single engagement typically lasting around 2.2 years.
The most common languages among freelancers in Germany who have used GAMP 5 in their recent projects are German (100%), English (93%), and French (33%).
The most common industries among freelancers in Germany who have used GAMP 5 in their recent projects are Pharmaceutical (87%), Information Technology (53%), and Manufacturing (53%).
The most common business areas among freelancers in Germany who have used GAMP 5 in their recent projects are Quality Assurance (93%), Information Technology (80%), and Project Management (73%).
Main locations of FRATCH Experts, who have recently used GAMP 5
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.
Berlin Hamburg Munich Cologne Frankfurt Stuttgart Dusseldorf Leipzig Dortmund Essen Bremen Dresden Hanover Nuremberg Request a free demo
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Philipp Thomaschewski
FRATCH CEO
