For a large pharmaceutical company, an IMP (Investigational Medicinal Product) Quality Manager is sought to ensure GMP compliance and product quality of investigational medicinal products. - Typical areas of responsibility in this role:** - Review and approval of manufacturing and batch records for Drug Substance and Drug Product. - Execution of the 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 of production and QC departments on all GMP-related and quality topics. - Planning and execution of internal audits and support during regulatory inspections and external audits. - Management and monitoring 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 repeat deviation rate 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 set timeframe (Target: > 90%). - Key challenges, risks or specifics:** - High complexity and variability due to development of new molecules and processes in the clinical phase. - Strict compliance with ever-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 disruptions for critical raw materials or services. - Ensuring data integrity across all quality-related systems. - Deliverables:** - Released batches of investigational products. - Approved master batch records and SOPs. - Completed and evaluated 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 to inspect weld seams on safety-critical body components. The project involves ensuring the highest quality standards through non-destructive testing methods. - Typical tasks: Independent planning, execution and evaluation of non-destructive tests (NDT), especially 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 and production planning. Calibration and maintenance of testing equipment. - Relevant technologies/tools: Ultrasonic testing equipment, endoscopes, videoscopes, CAQ software (e.g. Babtec, QSYS), knowledge of standards DIN EN ISO 9712, ISO 5817, and relevant VDA volumes. - KPIs/success metrics: First Pass Yield (FPY) > 98%, reduction of internal defect rate (PPM), zero-defect tolerance for safety-critical seams (Escape Rate = 0), timely completion of test orders. - Special challenges: Assessment of complex seam geometries under time pressure. Clear interpretation of test results and distinction between acceptable irregularities and critical defects. Enforcement of quality standards with production. - Deliverables: Completed test protocols, detailed failure 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 testing 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

As part of a digitization initiative, software quality will be ensured and improved through modern testing, analysis and review methods. 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. - Assessment and continuous advancement of QA processes, tools and metrics.

On behalf of a renowned client in the life sciences sector, we are seeking freelance support in the field of Clinical Data Management. The main responsibility is to coordinate all data management activities in clinical trials. - Typical areas of responsibility 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 investigational sites. - Medical coding of adverse events (AEs) and medications (e.g., with MedDRA, WHODrug). - Conducting SAE reconciliation (alignment of serious adverse events). - Preparation and execution of the database lock 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%. - Timeliness: 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 milestones and processes defined in the DMP. - 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 globally distributed investigational sites. - Shortage of qualified specialists and high demands for onboarding 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 database prepared for statistical analysis. - Final locked study database with complete audit trail. - Archived project documentation after study completion.

A company is seeking freelance support in the field of HSE management / safety specialist for a long-term project. The objective of the project is to ensure and coordinate safety measures on a construction site in Wiesbaden in accordance with legal and contractual requirements. The role includes responsibility for implementing and monitoring occupational health and safety measures, conducting training sessions and audits as well as creating and maintaining HSE reporting. The HSE Manager will work closely with clients, consortia and contractors to ensure compliance with safety standards. Key responsibilities: - Coordination of safety measures on the construction site in accordance with §4 of the Occupational Health and Safety Act - Alignment and coordination of occupational safety measures with contractors - Maintenance and updating of the HSE Site Manual - Conducting toolbox meetings - Participation in coordination meetings - Preparation and execution of trade-related risk assessments - Regular site inspections including reporting and photo documentation - Reporting and tracking of deficiencies and deriving appropriate measures - Conducting training and briefings in the field of HSE - Monitoring the use of personal protective equipment - Organizing and conducting HSE audits - Preparation and maintenance of HSE reporting - Reviewing relevant supplier documentation - Analysis of work accidents and near misses including preventive measures - Authority to issue instructions to contractors on HSE-related matters

A company is seeking support for a project aimed at transparently mapping the overall ordering process in the Portals area. The goal is to combine relevant data sources from order to activation to enable a holistic view of the end-to-end process. This should facilitate the identification of process deviations and optimization potentials. Key project milestones include connecting the required data sources, building self-service reports, and implementing automated alerts for deviations in the process flow. The challenge lies in the technical and professional integration of heterogeneous systems and data flows to ensure consistent monitoring and control of the ordering process. - Analysis and documentation of requirements in the Omnichannel area using requirements management tools and structured collection methods - Professional and technical analysis of existing data sources and ETL processes using database tools - Recording and evaluation of existing interfaces between source and target systems based on technical documentation - Consulting on technical integration of defined data sources into the Celonis environment considering the tools used (Celonis EMS, Data Pool and Data Push API) - Creation of technical queries and representations for process visualization based on provided platform functions (Celonis PQL, Studio) - Use of system-side functions for visualization and analysis of existing business processes (via Celonis Process Explorer) - Professional consulting on technical interfaces, data provision and systemic requirements

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 provider contracts within the scope of the corporate reorganization. - Development of a future-oriented 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 the operational readiness of facilities and buildings, managing maintenance activities. - Consolidation and tendering of FM services; negotiation and management of Service Level Agreements (SLAs). - Leadership of the internal FM team and coordination of external service providers. - Budget planning, control, and reporting to the executive 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 of the Planned Maintenance Percentage (PMP) to >80% to reduce reactive incidents. - 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 in 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 business continuity during the restructuring. - Balancing cost-cutting pressure 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 the target operating model. - Deliverable 2: Strategy paper, process map, and implementation roadmap. - Milestone 3: Successful completion of the service provider tender(s). - Deliverable 3: Signed new service contracts and handover plan. - Final deliverable: Handover documentation to the succeeding line management.

Ein Unternehmen sucht einen erfahrenen Technischen Redakteur, der für die Erstellung und Verwaltung von Datenblättern, Produktbroschüren und Katalogen verantwortlich ist. Diese Dokumente sind entscheidend für den Vertrieb, rechtsverbindlich und Teil der internen Qualitätssicherung. Die Produktbroschüren präsentieren die wesentlichen Produktmerkmale und den Kundennutzen, während die Datenblätter detaillierte Spezifikationen enthalten. Die Rolle umfasst die eigenverantwortliche Steuerung und Überwachung sämtlicher Korrektur- und Abstimmprozesse bis zur finalen Freigabe sowie die Sicherstellung der definierten Qualitäts- und Freigabeprozesse gemäß den Unternehmensrichtlinien. Zudem ist die Ablage der finalen Daten in den entsprechenden Systemen wie Promo-Office-Datenbank, PDM und Internet-CMS erforderlich. - Erstellung von Datenblättern, Produktbroschüren und Katalogen gemäß den Vorgaben. - Aufbereitung der Daten für die Druckproduktion und ISO-konforme Ablage im Produktmanagement-System. - Steuerung der versionierten Dokumente für Druckproduktion und Veröffentlichung in Online-Medien. - Sicherstellung der definierten Qualitäts- und Freigabeprozesse. - Ablage der finalen Daten in den entsprechenden Systemen.

An experienced consultant is sought for a process and project assignment in the area of Asset P&L (Profit and Loss) at a leading international financial services provider. - Typical responsibilities 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 weak points, 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 introducing IT systems (e.g., P&L engines, data warehouses). - Project management for implementing the 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 conducting 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 preparation time (cycle time): target >25% efficiency gain. - Decrease in manual correction bookings: target >50% reduction through process automation. - Data quality index: increase in "first-time-right" rate on data ingestion to >99%. - Efficiency ratio (cost-to-income): demonstrated positive contribution to lowering the ratio. - User adoption rate: acceptance of new processes/tools in the business units >80% after 3 months. - Specific challenges, risks, or peculiarities:** - 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 in an operational environment. - Concrete deliverables:** - Milestone 1: completed as-is analysis and process documentation. - Deliverable 1: detailed analysis report including assessment of weak points. - 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 the Works Council. - Set and deliver the 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: - Analyze existing insurance processes and identify digitalization potentials - Gather and document business requirements together with business units - Develop solution concepts for digital transformation (including process modeling and cost-benefit analyses) - Act as liaison between business and IT: translate requirements into technical concepts and support implementation - Support 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 cycle times, increase in customer satisfaction/user acceptance, reduction of manual efforts through automation Challenges: aligning diverse stakeholders in the insurance environment (business units, IT, regulatory), integrating new digital solutions into existing legacy systems, handling regulatory requirements and data protection, change management and user acceptance Deliverables: comprehensive requirement documents and process models, developed business concepts and user stories for IT implementation, defined implementation roadmap, training materials for changed processes Lessons Learned: early involvement of all stakeholders facilitates the execution of digitalization projects; iterative, agile approaches enable flexible adjustments; deep industry knowledge (products, regulation) is crucial for designing sustainable 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 required at short notice.**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 adjustment of controllers and I/O modules.- Creation and modification of process graphics, user interfaces, and alarm management configurations.- Execution of system tests, error analyses, and performance optimizations to ensure plant availability and controllability.- Technical support for operational personnel during the commissioning and ramp-up phases.- Preparation and maintenance of technical documentation (functional diagrams, configuration descriptions, test protocols).- Close collaboration with process engineering, electrical engineering, 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.- Bus systems: PROFIBUS, Foundation Fieldbus, Modbus.- Virtualization: VMware, Hyper-V for test and development environments.- Databases: SQL knowledge for historical data analysis (e.g. 800xA History).- Knowledge of relevant standards for process and power plant engineering (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 operational personnel on the new system environment.**Specific challenges, risks or specifics:**- Migration in 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 management, turbine control).- 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 technology, process engineering, and operations.**Concrete deliverables (“Deliverables”):**- Migrated and operational control logic on the target system.- Fully tested and customer-approved process graphics and user interfaces.- Acceptance protocols for Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).- Updated technical plant documentation.- Final migration report with lessons learned.- Trained operational personnel.

A company is seeking an experienced construction supervisor or construction manager in the fiber optic environment to provide professional support and supervision of the construction services of a general contractor in FTTH broadband expansion. The goal is to ensure that the construction services meet the execution planning specifications and that the FTTH broadband network is fully deployed. The construction sites are located near Würzburg and Saarbrücken. The role includes monitoring compliance with schedules, workplace safety requirements and quality of construction services as well as coordinating and documenting construction activities. The construction manager will independently create a site diary and overall documentation, track subcontracted services and verify the accuracy of plans and construction documents. - Professional support and supervision of the construction services of a general contractor in the FTTH broadband expansion. - Ensuring compliance with schedules, workplace safety requirements and the quality of construction services. - Recording and reviewing the plans and construction documents of external companies. - Independently creating a site diary and overall documentation. - Tracking, controlling and documenting ordered services and deliveries. - Site supervision and safety inspections of the construction site in accordance with the HSE concept.

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

Management of a strategic digitalization project within a hospital group, e.g. the implementation of a new HIS or a patient digital 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 rollout. - Ensuring compliance with regulatory requirements (KHZG, GDPR). - **Relevant Technologies, Tools & Methods:** - HIS systems (Orbis, iMedOne), patient digital record 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, extensive stakeholder management, interoperability, data security. - **Deliverables:** - Project plan, status reports, requirements specification, change concept, cutover plan, project closure report.

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

- A company is seeking an experienced interim procurement professional to support its Amsterdam office due to a departing colleague. - The role will end once a permanent successor is found, with the possibility of extension depending on the recruitment process. - The professional will act as the sole representative of a group-wide procurement organization in the Amsterdam office, working closely with a team of nine spread across Europe. - The role involves managing end-to-end procurement processes for both existing and new suppliers, focusing on Marketing and Professional Services categories. - The professional will ensure adherence to procurement standards, negotiate prices, and compare offers in collaboration with business owners. - The onboarding will primarily be remote, with occasional in-person days in Amsterdam.

An EPC consultant is looking for an experienced site manager (mechanical) to oversee a biogas plant project. The objective of the project is to supervise the construction and ensure that the mechanical works comply with the project requirements. In this role, you will take responsibility for construction supervision and coordinate on-site mechanical works. You will work closely with other project stakeholders to ensure adherence to schedules, quality standards, and safety regulations. - Supervise mechanical construction works on the biogas plant - Ensure compliance with schedules and quality standards - Coordinate subcontractors and suppliers - Conduct regular site inspections and reporting - Assist in resolving technical challenges on-site - Adhere to safety regulations and environmental standards