06.10.2026 aktualisiert

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Senior CSV Consultant (GxP) | Data Integrity, EU GMP Annex 11, GAMP 5 | AI Validation & Governance

Maikammer, Deutschland
Maikammer +50 km
Maikammer, Deutschland
Maikammer +50 km

Profilanlagen

Gerd_Reber_Master-CV_v11_6_1_202610.pdf
Gerd_Reber_Profile_AI-VAL_2026-10_EN.pdf
Gerd_Reber_Profile_CSV-ERP_2026-10_EN.pdf
Gerd_Reber_Profile_MFG-DI_2026-10_EN.pdf
Gerd_Reber_Profile_SW-ITQ_2026-10_EN.pdf

Über mich

Validation and governance of regulated systems. 20+ years of CSV, data integrity and software QA in pharma, medtech and IVD along GAMP 5, EU GMP Annex 11 and 21 CFR Part 11. ISO/IEC 27001 project led. Client engagement on AI-assisted continuous validation since 2026. Mathematician.

Skills

Agile MethodologieAgiles TestenKünstliche IntelligenzTest AutomationSoftware QualityData GovernanceData MigrationFmeaInformation GovernanceIt-GovernanceIso 13485ISO / IEC 27001Requirements EngineeringRequirements ManagementSoftware-ComplianceVerifizierung und ValidierungTest DesignTest ManagementTest ScriptsGmp-gerechte DokumentationGXP
FOCUS AREAS
  • Computer System Validation (CSV) in GxP environments: risk-based validation strategies along GAMP 5 (2nd edition), validation plans, risk assessments (FMEA), IQ/OQ/PQ, traceability matrices and validation reports
  • EU GMP Annex 11 and 21 CFR Part 11: gap assessments, electronic records and signatures, audit trails, user and access management, backup and restore; validation concepts anticipating the announced Annex 11 revision
  • Data integrity: DI frameworks and governance, ALCOA+, data integrity risk assessments in GMP and GCP, audit trail review processes and risk assessments
  • CAPA and deviation management: risk exception handling with conditions and deadlines, tracking to closure, effectiveness verification, periodic review
  • Supplier qualification: assessments and audits of software suppliers and service providers, supplier quality plans as evidence towards regulated customers, SLA review and responsibility matrices
  • SDLC and software quality assurance: requirements engineering, requirements traceability, test strategy and test design (positive, negative, boundary), defect management, release documentation
  • Project management of software development, agile and waterfall: planning, backlog and release management, team leadership, from requirements to regulated release
  • System validation: MES, SCADA with custom scripts (GAMP category 5), laboratory and quality systems, ALM and QM systems, data warehouses, SAP including data migration
  • Coordination with authorities: technical concepts agreed in written review rounds through to acceptance, e.g. connecting medical device software to a statutory patient registry; submission packages for GMP supervisory authorities (no product registration)
  • IT security in regulated environments: ISMS and ISO/IEC 27001:2022 certification, cybersecurity frameworks along NIST CSF, security controls integrated into validation and operations
  • Audit and inspection readiness: audit representation, submission packages for supervisory authorities, decision papers for management
  • AI in regulated environments: AI governance frameworks, risk-based classification of AI use cases, human oversight, validation concepts for AI-assisted processes, AI-supported continuous validation of software products

STANDARDS AND REGULATIONS
Applied: GAMP 5, EU GMP Annex 11, 21 CFR Part 11, 21 CFR Part 820, ALCOA+, ISO/IEC 27001, NIST CSF, EN ISO 13485, EN 62304, EN ISO 14971, IEC 62366, ISO/TR 80002-2, MDR, IVDR, ISO 9001
Working knowledge and framework work: EU AI Act, ISO/IEC 42001, NIST AI RMF, draft EU GMP Annex 22, EU Data Act, MDSAP, SOX

METHODS
Risk-based validation, FMEA moderation, gap analysis, requirements traceability, audit trail review, change and configuration management, retrospective validation, agile & V-model development

INDUSTRIES
Pharmaceuticals, medical devices, in-vitro diagnostics, suppliers to the pharmaceutical industry

LANGUAGES
German (native), English (fluent)



Erfahrung

Berufserfahrungmehr als 10 Jahre
Freelancer seit2002

Sprachen

DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnisseNiederländischGrundkenntnisse

Projekthistorie

Framework Conception - AI-Supported Continuous Validation of Software Products (client engagement)

Pharma und Medizintechnik

  • Conception of the framework for AI-supported continuous validation of software products
  • Definition of the validation strategy for an AI-assisted function in pharmaceutical production as the use case within the framework
  • Details are subject to a non-disclosure agreement

Validation of a Manufacturing Execution System (MES) in Sterile Production

Pharmaceutical contract manufacturer, sterile production, Germany

Pharma und Medizintechnik

  • Implementation and validation concept along GAMP 5 (2nd edition), anticipating the announced revision of EU GMP Annex 11
  • Requirements specification and FMEA-based risk analysis with end-to-end traceability to testing
  • Risk-based classification of all configuration parameters, determining the required depth of testing and documented evidence
  • Validation of the data migration from the legacy system: migration plan, verification of the migrated data, migration report
  • Responsibility matrix across client, system supplier and service provider, including SLA review and supplier governance
  • Submission package for regulatory acceptance; decision papers on scope, exclusions and residual risk

Senior CSV Expert - Validation and Test Framework for Custom SCADA Scripts (GAMP 5 Category 5)

Pharmaceutical company, vaccine manufacturing

Pharma und Medizintechnik

  • Validation strategy for custom-developed scripts and functions in a GxP-regulated SCADA system interfacing with MES for electronic batch records
  • Classification of script functions into GAMP 5 categories 4 and 5; requirements engineering based on source code documentation
  • Test strategy and OQ test protocols with positive, negative and boundary scenarios; supplier code reviews and functional specifications
  • Identification of compliance gaps and coordination with automation engineering, service providers and QA (21 CFR Part 11, EU GMP Annex 11, ALCOA+)
  • Roll-out and application of the framework in a pilot project

CAPA Manager Data Integrity / CSV - Risk Exception Handling and Control Operations

Pharmaceutical company

Pharma und Medizintechnik

  • Assessment of documented deviations and gaps; CAPA measures with conditions and deadlines, tracked to closure
  • Review of data integrity assessments and CAPAs for compliance and defensibility
  • Planning and monitoring of DI and CSV projects across the system landscape; DI assessments before go-live of new systems
  • Effectiveness verification at closure and periodic review; status reporting to quality management and leadership
  • Test specifications and CAPA measures for camera-based inline controls in production (label verification, closure control)

GCP Data Integrity Risk Assessment Programme - Clinical Development

Global pharmaceutical company, medicine division

Pharma und Medizintechnik

  • Process and system inventory across clinical, regulatory, pharmacovigilance and quality processes, mapped to SOPs, systems and process owners
  • Data integrity risk assessments with process visualisation, data mapping, risk identification and derivation of controls, sequenced against the GCP audit schedule
  • Assessment of clinical trial systems (randomisation, IRT, EDC, clinical document management) against ALCOA+
  • Consolidation of cross-process risk themes; concept for flagging data integrity events in the non-compliance, audit and inspection response process

Framework Lead / Project Manager - Data Integrity and CSV Governance Framework

Pharmaceutical packaging manufacturer (supplier to pharma)

Pharma und Medizintechnik

  • Initiated by a customer's supplier audit: framework built from the ground up for a company without a prior data integrity programme
  • Data integrity lifecycle for computerised systems, SOPs, templates, audit trail review process and training
  • System inventory and risk-based pre-assessment with GAMP 5 categorisation to prioritise the gap assessments
  • Gap assessment instrument covering user access, audit trail, electronic records and signatures, backup and restore, and CSV
  • CSV process with validation plan and report templates; site assessments and final report with a staged action plan

Project Lead - ISO/IEC 27001:2022 Certification

Translation service provider

Medien und Verlage

  • Leading the ISO/IEC 27001:2022 certification process
  • Build-up of the information security management system (ISMS): security policies, risk assessments, compliance procedures
  • Internal audits and preparation for the certification audit
  • Training on information security practices and requirements

Project Lead / Quality Manager - Quality Plan for Bioprocess Control Software (GAMP 5 Category 4)

Life science equipment manufacturer, bioprocess automation software

Pharma und Medizintechnik

  • Quality and project plan for the agile development of a process control software used in biopharmaceutical manufacturing (21 CFR Part 11, EU GMP Annex 11), serving as the supplier's good-practice evidence towards regulated customers
  • Elicitation of the actual development practice in structured expert sessions with written question catalogues
  • Roles and responsibilities, verification model with Definition of Ready and Definition of Done, risk-based test management and regression strategy
  • Change, configuration, defect and release management, document management with retention rules, backup and restore
  • Assessment criteria for suppliers and open-source components; gap check against the corporate procedure

Technical Project Manager - Medical Device Software (SaMD)

Digital health company, software as a medical device

Pharma und Medizintechnik

  • Release responsibility for regulated software releases of two market products, with the complete regulated record set and the MDR technical documentation for notified body review
  • Leadership of the development team: sprint planning, backlog and defect handling, release approval
  • Integration with a statutory national patient registry: concept agreed with the registry authority in written review rounds, implementation against the registry web service
  • New product from development to first market release, including an external penetration test with findings tracked to closure
  • Design and introduction of the company's CSV process; validation of the DevOps and product tool chain; supplier evaluations of cloud and platform providers

Quality & Change Manager

Medical device company

Pharma und Medizintechnik

  • Change management as the main responsibility over three years, carried out in an SAP-based change control solution
  • Final review and approval of changes, including distribution of final reviews within the quality management team
  • Setting up, planning and coordinating changes with all functions involved
  • Document and intermediate reviews, review and approval of labels, audit preparation
  • Camera-based inline label verification in insulin pump production, handled within change control and label approval

Program Manager - Legacy Systems Validation

Pharma und Medizintechnik

  • Programme management of a legacy systems validation across sites in the US, Germany, England and Ireland: project plan, budget, liaison with senior management
  • Validation strategy, validation and verification master plan and summary report; chairing of risk analysis sessions
  • Leadership of a team of consultants and testers and functional coordination of client staff
  • Process analysis in production and logistics, requirements, test protocols, validation registry and traceability matrix
  • Automated generation of the validation documentation and of a registry across all sites, with shared evidence produced once and site-specific evidence only where needed

Lead Auditor - Product Lifecycle and Development Processes

Laborgeräte / Life Science

Pharma und Medizintechnik

  • Audit of the product lifecycle with emphasis on the development processes, at a manufacturer entering the regulated pharmaceutical market
  • Justified choice of the audit criterion: instrument data used in pharmaceutical quality control brings the controlling application into the scope of GxP and electronic records requirements (GAMP 4)
  • On-site audit with interviews across quality, business, software, electronics, mechanics and production
  • Findings and recommendations for market readiness, presented to the client in plenary

Manager Business Systems; from July 1999 additionally Manager Engineering Systems

Automotive supplier

Automobil und Fahrzeugbau

  • Project management of the SAP R/3 implementation, followed by the implementation of a production planning and control system
  • Site responsibility for customer service centres, including budgets and IT organisation; company-wide functional responsibility for business systems, from July 1999 also for engineering systems (CAD, FEM, FMEA)
  • Establishment of new customer service centre sites at OEM locations: site and technical planning, project teams, budgets and formal acceptance
  • Project lead for the Euro conversion and the Year 2000 remediation across the business system landscape
  • Controlled-document environment for quality manuals and procedures in preparation for ISO 9000 and VDA 6.1 certification

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