Traceability Experts in Frankfurt

• Quality assurance and management of bioanalytical study data in LIMS and ELN systems
• Ensuring compliance with GLP and GCP in clinical studies
• Supporting project teams with quality- and compliance-related questions
• Quality assurance and compliance with regulatory requirements
• Assessment of data integrity, traceability, and study processes
• Close collaboration with QA, laboratory, and study teams in the pharmaceutical environment
• Qualification and validation of various devices (e.g. air samplers, data loggers, freezers, refrigerators, incubators)
• Maintenance and calibration of various devices (e.g. air samplers, data loggers, sensors)
• Deviation management (Deviations)
• Qualification and maintenance of monitoring systems (sensors for pressure, temperature, room temperature, and humidity), including alarm systems
• Execution of qualification and validation activities: CC, CQ, IQ, OQ, PQ, RA, CR, CAPA, DQ
• Preparation and review of URS, RTM, test plans, and qualification documentation
• Checking, maintaining, and tracking quality-related documentation

• Delivery of various end-customer projects in server and network infrastructure on time, in quality, and within budget.
• Project 1: Firewall renewal, replacement of an ASA firewall with a Fortinet firewall at an automotive supplier.
• Project 2: Migration of file services from dedicated servers at 5 branch locations into a central managed file service, including DHCP, directory, and print services, as well as decommissioning of the old domain controllers.
• Project 3: Renewal of the network infrastructure at the headquarters and branch locations of a logistics company and transition of the LAN, WLAN, and firewall environments into a managed network service.
• Project 4: Network renewal, replacement of the core and access switches at the headquarters of a medical technology company and transition into a managed network service.
• Project 5: Firewall renewal, replacement of an ASA firewall with a Fortinet firewall for a city.
• Environment: ASA and Fortinet firewalls, Cisco network components, ITSM Heat/Ivanti, Confluence.

Project: SCS (Settlement / Clearing Services)

Settlement platform serving multiple trading and clearing venues — counterparty risk safeguarding, settlement volume reduction, central risk management, and post-trade anonymity.

Technologies: Java 17, Spring Boot 3, Microservices, Spring Data JPA, SonarQube, Fortify (SCST), Mockito, Jenkins, OpenShift, Maven, Podman, GitHub, JIRA, Liquibase, Swagger, AMQP, Apache Camel, Terraform, PostgreSQL, Instana, Graylog.

• Identified and remediated CVEs in third-party libraries using SCA tooling, strengthening the security posture of production components.
• Maintained 90% code coverage with SonarQube, improving code quality and reducing production defects.
• Enabled mTLS for database authentication and message broker connections, enforcing encrypted, certificate-validated communication.
• Designed and deployed microservices with asynchronous, REST-based communication between components.
• Optimized a high-volume REST API (~200K requests) by reducing response time from 3s to 2s (33% improvement), boosting throughput and reliability under production load.
• Automated build and continuous integration pipelines using Maven and Jenkins.
• Orchestrated containerized workloads on Podman/OpenShift and governed schema evolution with Liquibase, ensuring reliable, repeatable deployments across all environments.
• Optimized Java code and implemented EHCache-based caching, improving application performance.
• Streamlined release management by governing application images, JAR versions, and dependencies through DBAG Artifactory, ensuring version consistency and audit traceability across environments

• Designing and optimizing the end-to-end supply chain for a newly established restaurant, covering fresh produce, dry goods, beverages, and kitchen essentials
• Setting up ordering cycles, ensuring food-safety compliant logistics, and aligning delivery schedules with kitchen operations to maintain product quality and reduce waste
• Building procurement frameworks and vendor relationships with major importers and wholesalers in Germany; structuring agreements to secure competitive food pricing, negotiating minimum order quantities, and establishing reliable delivery commitments
• Defining structured processes for supplier evaluation, contract negotiation, and delivery scheduling to reduce risks such as delayed deliveries, inconsistent product quality, or stock shortages; introducing clear evaluation criteria, establishing communication protocols with vendors, and setting escalation procedures for supply disruptions

• Coordinated documentation lifecycles ensuring compliance, approvals, and accessibility.
• Maintained and controlled master data in document management systems (M-Files, SharePoint).
• Prepared reports, dashboards, and presentations for senior management.
• Supported internal/external communication and formal reviews.
• Improved knowledge management through metadata validation and version control.
• Oversaw approval workflows, documentation compliance, and master data management.
• Provided advisory support to stakeholders on IT documentation and archiving standards.
• Implemented and supported change and problem report management processes within ITSM framework.
• Prepared KPI dashboards and structured reports to monitor CM deliverables and track compliance.
• Maintained and improved documentation workflows in M-Files and Confluence, ensuring metadata accuracy and GDP compliance.
• Tools: M-Files, Jira, Confluence, SharePoint, MS Office

• Define the QA strategy and plan for the above mentioned OEMs project.

• Identify applicable processes, methods, and standards to be followed (eg, GS_95014, KGAS, ISO/IEC 15504, ISO 26262, ISO 21434, etc.).

• Plan reviews, audits, and assessments as per the strategy.

• Check whether the project follows defined processes (System, software, mechanical, hardware, testing, change, configuration, problem, risk etc.) as per strategy.

• Provide QA support to software process: software requirement analysis, software architectural design, software detailed design and unit construction, software unit verification, software component verification and integration verification, software verification processes.

• Monitor compliance with organization-wide and project-specific standards.

• Verify that deviations are documented and escalated.

• Review work products (requirements, design docs, test cases, code, reports (MISRA, C0, C1, coding standards), etc.).

• Check compliance with standards, templates, and checklists.

• Ensure that bi-directional traceability exists (e.g., requirements ↔ design ↔ tests).

• Give objective evidence (not influenced by delivery pressure) during assessments.

• Identify non-conformances (process not followed, missing approvals, wrong standard).

• Report deviations and track them until closure.

• Verify that corrective actions are implemented (5why, Ishikawa, 8D, FMEA, FTA, DFM, DRP, PCC, LLBP, PDCA).

• Provide QA status reports to management and project stakeholders.

• Highlight risks related to process non-compliance.

• Deliver objective evidence for assessments/audits (e.g., ASPICE, ISO/IEC 15504, ISO 26262, ISO 21434, ISO_PAS_8800).

• Collect and analyze QA findings.

• Suggest process improvements.

• Support lessons learned activities.

• Achieved ASPICE Level 1 and Level 2 for multiple Audi and Mercedes-Benz projects assessments.

• Systems & Requirements Engineering: Requirements elicitation, traceability, and change management across the V-model
• System-level responsibility for Active Sound and AVAS functions within hybrid and electric vehicle programs
• Definition, refinement, and maintenance of system and software requirements with strong focus on AVAS regulatory compliance
• Management of development backlog and user stories within SAFe PI cadence, ensuring clear acceptance criteria
• Analysis and assessment of change requests, including impact on system behavior and delivery timelines
• System interface between software development, vehicle integration, testing, and homologation stakeholders
• Coordination of system, software, and vehicle-level testing, including support of homologation-relevant validation activities
• Support of feature releases and integration across multiple vehicle platforms and variants
• Development and delivery aligned with ASPICE Level 2 processes and internal quality standards, including system and vehicle-level validation, test drive support, and homologation-relevant activities
• Ensuring functional safety (ISO 26262) and automotive cybersecurity (ISO 21434) compliance within system development contexts
• Compliance with ASPICE processes, EuroNCAP requirements, and vehicle-level regulatory and homologation constraints

• Qualification of filling lines
• Preparation of IQ, OQ, PQ documents and reports
• Conducting FAT and SAT
• Alarm lists: creating and performing tests
• Preparation of GMP-compliant documentation (qualification plan, URS, risk analysis, IQ, OQ, PQ and qualification report)

• Creating test concepts
• Creating test plans and packages in the Test Suite module of SolMan
• Defining test objects, test types (manual, automated), and schedules
• Coordinating and tracking all test activities
• Maintaining and versioning test cases in SolMan
• Supporting the test team in various test activities
• Checking links between test cases and requirements
• Ensuring traceability between test cases and requirements
• Controlling and monitoring test execution
• Managing error messages directly in SolMan
• Tracking and re-testing after bug fixes
• Working with the release manager, developers, and key users
• Managing error messages (defects) directly in SolMan
• Tools: SolMan, SAP S/4HANA

• Interim project manager and requirements engineer in various client projects

• Designed and implemented a global lifecycle programme across EMEA, APAC & NA, unifying processes and systems to improve vendor coordination and operational efficiency
• Developed and deployed supporting systems and processes, enhancing traceability and service reliability across logistics operations
• Introduced a standardised Service Test & Validation framework, improving quality assurance and reducing deployment errors

• Senior consultant for Project Management Office & Governance
• Analyze and optimize existing process landscapes to identify bottlenecks and improvement opportunities
• Structure and further develop project processes to increase efficiency and ensure sustainable implementation
• Establish and operationalize project governance to ensure clear responsibilities and control mechanisms
• Build tracking and controlling structures to make processes measurable and manageable
• Harmonize interfaces and process flows to reduce coordination efforts and maximize efficiency
• Manage stakeholders and communications to ensure consistent, process-oriented collaboration
• Facilitate meetings/workshops
• Tools: MS Project, MS Office, MS SharePoint, MS Visio
• Skills: Analysis, Process Management, Governance, Tracking, Controlling, Stakeholder Management, Communication Control, Facilitation, Process Optimization