For a large pharmaceutical company, an IMP (Investigational Medicinal Product) Quality Manager is sought to ensure GMP compliance and quality of investigational products. **Typical responsibilities in this role:** - Review and approval of manufacturing and batch protocols (Batch Records) for drug substance and drug product. - Execution of final quality release of investigational products for use in clinical trials. - Review and approval of GMP-relevant documents such as SOPs, validation reports, deviations and change control requests. - Creation and maintenance of product-specific quality agreements with internal and external partners. - Support for production and QC departments on all GMP-related questions and quality issues. - Planning and conducting internal audits and support during regulatory inspections and external audits. - Management and oversight of CAPA (Corrective and Preventive Actions) measures for sustainable problem resolution. **Relevant technologies, tools or methods:** - Quality management systems (QMS): Veeva Vault QMS, MasterControl, TrackWise, SAP QM. - Document Management Systems (DMS): Veeva Vault, OpenText Documentum. - ERP systems: SAP S/4HANA (especially QM module). - Laboratory Information Management Systems (LIMS). - Manufacturing Execution Systems (MES). - Methods: risk analysis (FMEA), root cause analysis (5 Whys, Ishikawa), statistical process control (SPC). **Typical KPIs or success metrics:** - Batch Release Time: average time from production completion to final release (target: < X days). - Right-First-Time Rate: percentage of batches released without deviations or rework (target: > 95%). - CAPA Effectiveness: reduction in recurrence rate of deviations after CAPA implementation (target: > 80%). - Audit Performance: number of critical/major findings in internal and external audits (target: 0). - Deviation Closure Rate: percentage of deviations closed within the defined timeframe (target: > 90%). **Key challenges, risks or specifics:** - High complexity and variability due to the development of new molecules and processes in the clinical phase. - Strict adherence to constantly evolving GMP regulations (e.g. EU Annex 1 for sterile products). - Ensuring product quality and patient safety under high time pressure (time-to-market). - Managing interfaces between development, manufacturing, QC, and regulatory affairs. - Risk of supply chain interruptions for critical raw materials or services. - Ensuring data integrity in all quality-relevant systems. **Concrete deliverables:** - Released batches of investigational products. - Approved master batch records and SOPs. - Completed and assessed deviation and change reports. - Audit and inspection reports with tracked action plans. - Valid quality agreements with all relevant partners. - Regular quality reports for management.

A leading automotive supplier is seeking an experienced quality expert for the inspection of weld seams on safety-critical body components. The project includes ensuring the highest quality standards through non-destructive testing methods. - Typical tasks: Independent planning, execution and evaluation of non-destructive tests (NDT), in particular visual testing (VT) and ultrasonic testing (UT). Creation and management of test plans and work instructions. Detailed documentation of test results in CAQ systems. Analysis of defect patterns and initiation of corrective actions in close coordination with welding shop and production planning. Calibration and maintenance of testing equipment. - Relevant technologies/tools: Ultrasonic testing devices, endoscopes, videoscopes, CAQ software (e.g. Babtec, QSYS), knowledge of standards DIN EN ISO 9712, ISO 5817, as well as relevant VDA volumes. - KPIs/success metrics: First Pass Yield (FPY) > 98%, reduction of internal defect rate (PPM), zero-defect tolerance on safety-critical seams (escape rate = 0), on-time completion of test orders. - Special challenges: Evaluating complex seam geometries under time pressure. Clear interpretation of test results and distinguishing between permissible irregularities and critical defects. Enforcing quality standards against production. - Deliverables: Completed test protocols, detailed defect analyses and reports, updated work and test instructions, contributions to FMEAs (Failure Mode and Effects Analysis). - Best practices: Regular team coordination (shopfloor management), continuous improvement of test processes (CIP), raising awareness and training of production staff.

A company is seeking an experienced engineering expert for sterile filling to support a challenging project in pharmaceutical production. The goal of the project is to optimize the efficiency and quality of filling processes and ensure compliance with all regulatory requirements. In this role, the expert will work closely with the internal team to develop technical solutions, analyze existing processes and implement improvements. Main Tasks: - Analysis and optimization of processes in sterile filling - Ensuring compliance with GMP and other regulatory requirements - Development and implementation of technical solutions for process improvement - Collaboration with interdisciplinary teams - Documentation and reporting of progress and results

Within the scope of a digitization initiative, software quality is to be ensured and improved through modern testing, analysis, and review procedures. The goal is to increase development quality and efficiency through strategic measures and coaching. - Definition, monitoring, and improvement of test coverage strategies for critical software components. - Organization and execution of code reviews in compliance with coding standards, architectural, and security requirements. - Setup, execution, and evaluation of SonarQube analyses, as well as coordination of the remediation of technical debt and security vulnerabilities. - Training and support of developers in Clean Code, TDD, and CI/CD practices. - Evaluation and continuous further development of QA processes, tools, and metrics.

In assignment for a renowned client in the life sciences sector, a freelance support is sought in the area of Clinical Data Management. The main task is taking responsibility for coordinating all data management activities in clinical trials. - Typical responsibilities in this role:** - Creation and review of the Data Management Plan (DMP) and the Data Validation Plan (DVP). - Design and implementation of electronic case report forms (eCRFs) in EDC systems (Electronic Data Capture). - Coordination of data collection, validation, and cleaning throughout the study lifecycle. - Development and execution of query processes to resolve data inconsistencies with investigative sites. - Medical coding of adverse events (AEs) and medications (e.g., using MedDRA, WHODrug). - Conducting SAE reconciliation (matching serious adverse events). - Preparation and execution of database locks after data collection is complete. - Preparation of status reports and communication with the study team (project management, monitoring, biostatistics). - Relevant technologies, tools, or methods:** - EDC Systems: Medidata Rave, Oracle Clinical, Viedoc, Zelta, OpenClinica. - Programming/analysis tools: SAS, R, Python, SQL. - Standards: CDISC (SDTM, ADaM), GCP (Good Clinical Practice), 21 CFR Part 11. - Collaboration tools: MS Teams, Jira, Confluence. - Data visualization: Tableau, Power BI. - Typical KPIs or success metrics:** - Data quality: Query rate (number of queries per 1,000 data points) < X; data entry error rate < 1%. - Time management: Time from last patient last visit (LPLV) to database lock (target: 4–6 weeks). - Efficiency: Average time to query resolution (target: < 10 business days for critical queries). - Compliance: 100% adherence to DMP-defined milestones and processes. - Protocol adherence: Rate of protocol deviations related to data management < 5%. - Key challenges, risks, or specifics:** - Managing increasing volumes and sources of data (e.g., wearables, ePROs). - Ensuring data integrity and security (cybersecurity, data protection/GDPR). - Complexity due to mid-study changes (protocol amendments) and their impact on the database. - Ensuring consistent data quality across multiple global investigative sites. - Shortage of qualified specialists and high demands for onboarding in study-specific systems. - Concrete deliverables:** - Finalized and approved Data Management Plan (DMP). - Live and validated study database (EDC system). - Regular data cleaning reports and status updates. - Clean, quality-assured, and analysis-ready database. - Final locked study database with complete audit trail. - Archived project documentation after study close-out.

Ein Unternehmen sucht eine freiberufliche Unterstützung im Bereich HSE-Management / Sicherheitsfachkraft für ein langfristiges Projekt. Ziel des Projekts ist die Sicherstellung und Koordination der sicherheitstechnischen Maßnahmen auf einer Baustelle in Wiesbaden gemäß gesetzlichen und vertraglichen Vorgaben. Die Rolle umfasst die Verantwortung für die Umsetzung und Überwachung von Arbeitsschutzmaßnahmen, die Durchführung von Schulungen und Audits sowie die Erstellung und Pflege von HSE-Berichtswesen. Der HSE-Manager wird eng mit Kunden, Konsorten und Kontraktoren zusammenarbeiten, um die Einhaltung der Sicherheitsstandards zu gewährleisten. Key responsibilities: - Koordination der sicherheitstechnischen Maßnahmen auf der Baustelle gemäß §4 Arbeitsschutzgesetz - Abstimmung und Koordination der Arbeitsschutzmaßnahmen mit den Kontraktoren - Pflege und Aktualisierung des HSE-Site Manuals - Durchführung von Toolbox-Meetings - Teilnahme an Koordinationsgesprächen - Erstellung und Durchführung gewerke-bezogener Gefährdungsbeurteilungen - Regelmäßige Baustellenbegehungen inkl. Berichterstattung und Fotodokumentation - Meldung und Nachverfolgung von Mängeln sowie Ableitung geeigneter Maßnahmen - Durchführung von Schulungen und Unterweisungen im Bereich HSE - Überwachung der Nutzung persönlicher Schutzausrüstung - Organisation und Durchführung von HSE-Audits - Erstellung und Pflege des HSE-Berichtswesens - Prüfung relevanter Lieferantenunterlagen - Analyse von Arbeits- und Beinaheunfällen inkl. Präventionsmaßnahmen - Weisungsbefugnis gegenüber Kontraktoren in HSE-relevanten Themen

A traditional, medium-sized branded goods company in northern Germany is seeking a freelance consultant and FM expert for 6 to 9 months to reorganize business activities in Corporate Real Estate Management (CREM) and Facility Management (FM). - Typical tasks in this role:** - Analysis of existing FM and CREM structures, processes, and service contracts as part of the corporate reorganization. - Development of a forward-looking strategy for corporate real estate and facility management to support the new business objectives. - Optimization of space management (space efficiency, workplace concepts, repurposing) in line with "Future of Work" strategies. - Realignment of operational facility management: ensuring operational readiness of equipment and buildings, managing maintenance activities. - Consolidation and tendering of FM services; negotiation and management of service level agreements (SLAs). - Leading the internal FM team and managing external service providers. - Budget planning, control, and reporting to senior management. - Relevant technologies, tools or methods:** - CAFM / IWMS: Planon, ARCHIBUS, Spacewell, SAP RE-FX, PMWeb. - ERP systems: SAP S/4HANA, Oracle. - Project management: MS Project, Asana. - Office suite: MS Office / Google Workspace. - Methods: Benchmarking, SLA management, Life Cycle Cost Analysis (LCC). - Typical KPIs or success metrics:** - Reduction of operational FM costs per m² by >10% through process optimization and consolidation. - Increase in Planned Maintenance Percentage (PMP) to >80% to reduce reactive failures. - Improvement of SLA compliance by external service providers to >95%. - Reduction of asset downtime for critical infrastructure by >20%. - Successful achievement of defined reorganization milestones within time and budget. - Key challenges, risks or specifics:** - High resistance to change within the existing organization (change management). - Lack of transparency due to fragmented data and missing digital processes. - Complexity in renegotiating or terminating long-standing service provider contracts. - Ensuring operational continuity during restructuring. - Balancing cost reduction pressures with maintaining service quality and employee satisfaction. - Concrete deliverables:** - Milestone 1: Completion of the as-is analysis and presentation of results. - Deliverable 1: Detailed assessment report with SWOT analysis and benchmarking. - Milestone 2: Approval of the new FM/CREM strategy and target operating model. - Deliverable 2: Strategy paper, process map, and implementation roadmap. - Milestone 3: Successful completion of service provider tender(s). - Deliverable 3: Signed new service contracts and handover plan. - Final Deliverable: Handover documentation to subsequent line management.

We are seeking an experienced consultant for a process and project initiative in the area of Asset P&L (Profit and Loss) at a leading international financial services provider. - Typical areas of responsibility in this role:** - Analysis and documentation of existing end-to-end P&L processes for various asset classes (e.g., equities, fixed income, derivatives). - Identification of weaknesses, risks, and inefficiencies in data collection, processing, and reporting. - Design and conceptualization of optimized target processes for P&L calculation and attribution. - Development of functional specifications and business requirements for adapting or implementing IT systems (e.g., P&L engines, data warehouses). - Project management for the implementation of new processes and tools, including milestone planning, stakeholder management, and test coordination. - Development of control mechanisms to ensure data quality and consistency. - Creation of training materials and delivery of workshops for business units (trading, controlling, risk). - Relevant technologies, tools or methods:** - Advanced analytics: MS Excel (Pivot, Power Query, VBA), SQL. - Business intelligence: Tableau, Power BI, Qlik. - Project management: Jira, Confluence, MS Project. - ERP/finance systems: SAP FI/CO, Oracle Financials, or industry-specific asset management platforms. - Methods: Business Process Model and Notation (BPMN 2.0), agile project management (Scrum/Kanban). - Typical KPIs or success metrics:** - Reduction of P&L generation time (cycle time): target >25% efficiency gain. - Decrease in manual corrective postings: target >50% reduction through process automation. - Data quality index: increase of the "first-time-right" rate in data acquisition to >99%. - Efficiency ratio (cost-to-income): demonstrable positive impact on lowering the ratio. - User adoption rate: acceptance of new processes/tools by the business >80% after 3 months. - Key challenges, risks or specifics:** - Heterogeneous system landscapes and inconsistent data sources (data silos). - High complexity of financial products and valuation models. - Resistance to process changes in business units (change management). - Ensuring compliance with regulatory requirements (e.g., IFRS 9, BCBS 239). - Time- and budget-critical implementation during ongoing operations. - Concrete deliverables (“Deliverables”):** - Milestone 1: Completed as-is analysis and process documentation. - Deliverable 1: Detailed analysis report including assessment of weaknesses. - Milestone 2: Finalized target concept and Business Requirements Document. - Deliverable 2: Implementation roadmap and project plan. - Milestone 3: Successful User Acceptance Test (UAT) of the new process/tool. - Deliverable 3: Acceptance protocols, training materials, and project closure report.

A company is seeking a Specialist/Consultant in system testing for special purpose machinery development. The System Test and Qualification group performs system tests in development projects, including testing individual components, machine modules and software releases. Responsibilities also include defining and conducting acceptance tests. The project’s objective is to support the detailed planning of test tasks, creation and optimization of test case specifications, as well as conducting integration and functional tests. All activities are performed on-site in the lab on machine systems. - Detailed planning of test tasks - Creation and optimization of test case specifications - Conducting integration and functional tests - Execution of test cases (Black Box, Use Case, Fail Case Tests) - Documentation and preparation of test results in the test management tool and MS Office - Fault analysis and communication with developers (directly in the lab and via MS Teams) - Coordination with project management and the test manager

A company is looking for an Interim Head of Hr Country Services for Germany and Austria to cover a 13-month fixed-term contract while the current incumbent is on sabbatical leave. The role involves driving excellence in Hr service delivery, managing labour relations, overseeing local policies and compliance, and leading a team of Hr representatives and Health & Safety Officers. The position is based in Germany with flexible (hybrid) work arrangements and may require up to 15% domestic and international travel.- Drive labour relations strategy and manage relations with Works Council.- Set and deliver local reward strategy, including salary negotiations and benefits management.- Act as a mediator in employee-manager conflicts and recommend corrective actions.- Lead the HR Country Committee and advise leadership on employment matters.- Manage labour law issues, government audits, and represent the company in court if needed.- Ensure compliance with local regulations, privacy laws, and Group Policies.- Supervise HR Representatives and OHS Officers.-Support HR Business Partners in driving employee engagement actions.

Typical tasks: - Analyzing existing insurance processes and identifying digitalization potentials - Gathering and documenting business requirements together with the business units - Creating solution concepts for digital transformation (including process modeling and cost-benefit analyses) - Acting as liaison between business and IT: translating requirements into technical concepts and supporting implementation - Supporting project management in planning and deploying new digital solutions (agile methods such as Scrum/Kanban) Relevant tools & technologies: BPMN modeling tools (e.g. Visio, Signavio), requirements management (Jira, Confluence), knowledge of common insurance IT systems, MS Office KPIs & metrics: adherence to project milestones and budgets, reduction of process lead times, increase in customer satisfaction/user adoption, reduction of manual efforts through automation Challenges: coordinating multiple stakeholders in the insurance environment (business units, IT, regulatory), integrating new digital solutions into existing legacy systems, dealing with regulatory requirements and data protection, change management and user adoption Deliverables: comprehensive requirements documents and process models, developed business concepts and user stories for IT implementation, defined implementation roadmap, training materials for updated processes Lessons learned: early involvement of all stakeholders facilitates the implementation of digitalization projects; iterative, agile approaches enable flexible adjustments; in-depth industry knowledge (products, regulation) is crucial for designing viable digital solutions

For a project in the power plant environment, a freelance specialist for the migration and adaptation of the ABB 800xA control system is urgently sought. - Typical tasks in this role:** - Implementation of programming and commissioning with the ABB 800xA process control system. - Migration of existing control system logic to the new system version, including adaptation of controllers and I/O modules. - Creation and adaptation of process displays, operator interfaces, and alarm management configurations. - Execution of system tests, error analysis, and performance optimizations to ensure plant availability and controllability. - Technical support for operations personnel during the commissioning and ramp-up phase. - Preparation and maintenance of technical documentation (functional diagrams, configuration descriptions, test protocols). - Close collaboration with the process engineering, electrical engineering departments, and the plant operator. - Relevant technologies, tools or methods:** - Control system: ABB Ability™ System 800xA (including AC 800M controller, Information Management, Batch Control). - Engineering tools: Control Builder M, Process Graphics Migration Tool, Bulk Data Manager. - Fieldbus systems: PROFIBUS, Foundation Fieldbus, Modbus. - Virtualization: VMware, Hyper-V for test and development environments. - Databases: SQL knowledge for analysis of historical data (e.g. 800xA History). - Knowledge of relevant standards for process and power plant technology (e.g. IEC 61508, IEC 61511). - Typical KPIs or success metrics:** - Migration speed: number of migrated system components/functions per week/month. - System availability: control system uptime after migration > 99.9%. - Commissioning error rate: number of critical software bugs after go-live < 5. - Test coverage: percentage of successfully executed and documented test cases > 95%. - Adherence to project schedule: completion of migration and commissioning by the defined deadline. - Operator acceptance: positive feedback from operations personnel on the new system environment. - Specific challenges, risks or peculiarities:** - Migration during live operation (“brownfield”) with minimal downtime. - Ensuring compatibility between old and new system components (hardware/software). - High complexity of process logic in power plants (e.g. boiler control, turbine regulation). - Risk of cybersecurity vulnerabilities in networked control systems (e.g. CVEs for 800xA). - Management of interfaces to third-party systems (e.g. MES, ERP). - Need for intensive and precise collaboration between control engineering, process engineering, and operations. - Concrete deliverables:** - Migrated and operational control logic on the target system. - Fully tested and customer-approved process displays and operator interfaces. - Acceptance protocols for Factory Acceptance Test (FAT) and Site Acceptance Test (SAT). - Updated technical plant documentation. - Final migration report with lessons learned. - Trained operations personnel.

- Construction management for the installation of electrical systems in the context of a grid connection project - Ensuring compliance with budget, schedule and quality objectives as well as all relevant legal regulations - Reviewing technical documents such as construction plans, material lists and performance records - Coordination and communication with subcontractors, suppliers and project stakeholders - Interface management and ensuring a smooth project process

An organization is seeking an experienced construction supervisor or site manager in the fiber optics environment to professionally accompany and oversee the construction services of a general contractor in FTTH broadband deployment. The goal is to ensure that the construction services comply with the requirements of the execution planning and that the FTTH broadband network is fully rolled out. The construction sites are located near Würzburg and Saarbrücken. The role includes monitoring compliance with schedules, occupational safety requirements, and quality of construction services, as well as coordinating and documenting construction activities. The site manager will independently create a construction diary and a complete documentation, track subcontracted services, and verify the accuracy of planning and construction documents. - Professional accompaniment and oversight of a general contractor's construction services in FTTH broadband expansion. - Ensuring adherence to schedules, occupational safety requirements, and the quality of construction services. - Recording and reviewing the planning and construction documents of third-party companies. - Independently creating a construction diary and complete documentation. - Tracking deadlines, controlling, and documenting ordered services and deliveries. - Construction supervision and safety control of the construction site according to the HSE concept.

A company is looking for an expert with comprehensive technical expertise in cadastral surveying in North Rhine-Westphalia. The aim of the project is to optimize the business processes of the cadastral authorities and to incorporate scientific findings from the fields of geodesy and artificial intelligence to develop innovative solutions. The role requires a combination of practical experience, scientific work, and the ability to analyze and improve complex processes. Key responsibilities: - Analysis and optimization of the business processes of the cadastral authorities in NRW - Application of scientific findings in geodesy and artificial intelligence - Development and implementation of innovative solutions - Collaboration with interdisciplinary teams - Preparation of reports and presentations for stakeholders

Steering a strategic digitalization project in a hospital network, e.g. the implementation of a new HIS or an electronic patient record (ePA) in accordance with the KHZG. - **Typical areas of responsibility:** - Overall responsibility for project planning, control and monitoring (time, budget, quality). - Management of the interdisciplinary project team. - Requirements, risk and stakeholder management. - Planning and management of change management and rollouts. - Ensuring compliance with regulatory requirements (KHZG, GDPR). - **Relevant technologies, tools & methods:** - HIS systems (Orbis, iMedOne), ePA solutions. - Standards: HL7, FHIR. - Methods: PRINCE2, PMI/PMBOK, agile/hybrid. - Tools: MS Project, Jira, Confluence. - **Typical KPIs & success metrics:** - KHZG compliance, user adoption rate (>85%), process efficiency, milestone adherence. - **Key challenges & risks:** - High process complexity, intensive stakeholder management, interoperability, data security. - **Deliverables:** - Project plan, status reports, requirements specification, change concept, cutover plan, project closure report.

An EPC consultant is seeking an experienced Construction Manager (Mechanical) for the execution of a biogas plant. The goal of the project is the construction supervision and ensuring mechanical works are carried out in accordance with project requirements. In this role, you take responsibility for construction supervision and coordinate the mechanical works on site. You work closely with other project stakeholders to ensure compliance with schedules, quality standards and safety regulations. - Supervision of mechanical construction works at the biogas plant - Ensuring adherence to schedules and quality standards - Coordination of subcontractors and suppliers - Conducting regular site inspections and reporting - Assisting in resolving technical challenges on site - Compliance with safety regulations and environmental standards

A company is looking for an experienced Senior IT Consultant with a focus on Oracle HCM. The project’s goal is to support the management of the HR IT Data Management unit as well as the implementation and further development of HR IT systems in line with business requirements and strategic HR objectives. The consultant will play a key role in the GDPR-compliant provision of IT services, project initiation and execution, and collaboration with internal and external service providers. - Support in managing the HR IT Data Management unit - Strategy and organizational consulting - Implementation of HR IT systems for company-wide and internal data management - Ensuring GDPR-compliant provision of IT services - Conducting project initiation, planning, and execution - Collaboration with service providers and analysis of the cost-effectiveness of system application - Technical advancement of HR IT systems and implementation of innovative impulses, e.g., AI solutions

A company is looking for an experienced construction manager who specializes in pipe works. The goal of the project is to manage and supervise construction activities, particularly in the area of pipes with a diameter of DN2000. The construction manager will be responsible for planning, coordinating and carrying out pipe segment cutting operations. The position is entirely on-site in Düsseldorf. - Managing and supervising construction projects in the field of pipe works - Planning and execution of pipe segment cutting operations - Ensuring compliance with safety and quality standards - Coordination of teams and resources - Documentation and reporting on project progress

- IT project manager activities - Interface / bridging function between business domain and technology, hence the required compelling subject matter expertise.