Project details
Recommended projects
IMP Quality Manager (m/f/d)
A large pharmaceutical company is looking for an IMP (Investigational Medicinal Product) Quality Manager to ensure GMP compliance and the quality of clinical trial materials.
- Typical tasks in this role:**
- Review and approval of manufacturing and batch records for drug substances and drug products.
- Final quality release of clinical trial materials for use in studies.
- Review and approval of GMP-related 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 questions and quality topics.
- Planning and execution of internal audits and support during regulatory inspections and external audits.
- Management and monitoring of CAPA actions 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 and 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 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 clinical phases.
- Strict compliance with 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 ("Deliverables"):**
- Released batches of clinical trial materials.
- 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.
Sterile Filling Engineering Expert (m/f/d)
A company is looking for an experienced engineering expert in sterile filling to support a demanding project in pharmaceutical production. The goal of the project is to optimize the efficiency and quality of the filling processes and ensure that all regulatory requirements are met.
In this role, the expert will work closely with the internal team to develop technical solutions, analyze existing processes, and implement improvements.
Main tasks:
- Analyze and optimize processes in sterile filling
- Ensure compliance with GMP and other regulatory requirements
- Develop and implement technical solutions for process improvement
- Collaborate with interdisciplinary teams
- Document and report on progress and results
New
SAP ISU Expert with EEG Billing (m/f/d)
An organization is looking for an experienced SAP ISU expert with a specific focus on EEG billing. The goal of the project is to optimize and further develop processes in the area of EEG billing within the SAP ISU system.
In this role, the expert will work closely with internal teams to ensure that EEG billing processes run efficiently and comply with regulations.
- Analysis and optimization of existing EEG billing processes
- Implementation of new features and adjustments in SAP ISU
- Collaboration with internal stakeholders to ensure compliance with legal requirements
- Support in troubleshooting and system maintenance
- Documentation and training of relevant teams
Argo SAP Basis Architect
A company is looking for an experienced SAP Basis Architect to implement technical components in applications based on SAP S4, SAP BW4HANA, JavaScript, ABAP, SQLScript, and SAP HANA-native architecture. The focus is on roles and authorizations as well as SAP Basis–related tasks.
Responsibilities include maintaining roles and authorizations in SAP ECC, applying and introducing the XAMS tool, creating system documentation, communicating with technical operations, and supporting transports and transport packages. The role also covers handling technical Basis topics such as performance, parameter settings, networking, and development.
- Implementation of technical components in SAP systems
- Maintenance of roles and authorizations in SAP ECC
- Introduction and application of the XAMS tool
- Creation of system documentation
- Support for transports and transport packages
- Implementation of OSS Notes
- Management of technical Basis topics (performance, networking, parameter settings)
MES consultant specializing in Hydra X (m/f/d)
A company is looking for an experienced MES consultant with a focus on MPDV’s Hydra X to support the expansion of the system to additional sites.
The system is already rolled out at one site and now needs to be scaled further.
The role includes supporting the introduction of new features or versions of the system, implementing system customizations and optimizations based on production requirements, and assisting with the rollout. The consultant will work closely with internal teams and external service providers to ensure quick identification and resolution of issues in the MES system.
- Support the introduction of new system features or versions
- Implement system customizations and optimizations based on production requirements
- Assist with the rollout to additional sites
- Quickly identify and resolve issues in the MES system
SAP Basis Administrator (m/f/d)
A company is looking for an experienced SAP Basis Administrator, specializing in the administration and operation of the SAP Basis system landscape. The focus of the project is to ensure stable and high-performing SAP Basis operations and to support the ongoing SAP S/4HANA transformation. The administrator will also contribute to system relocations, migrations, and the parallel operation of legacy systems, as well as handle troubleshooting, performance optimization, monitoring, and user management.
- Administration and operation of the SAP Basis system landscape
- Support in the deployment and operation of SAP systems on IBM Power systems (Unix)
- Participation in the ongoing SAP S/4HANA transformation
- Involvement in system relocations, migrations, and parallel operation of legacy systems
- Troubleshooting, performance optimization, monitoring, and user management
New
Interim Disposition Manager for Production Material (m/f/d)
- Operational control and management of material requirement planning and provisioning, as well as maintenance of material master data for an efficient material flow
- Ensuring and monitoring the operational material flow and proactively initiating measures in case of deviations, in close coordination with suppliers and internal stakeholders
- Optimizing inventory levels in terms of tied-up capital costs, material coverage, and demand fulfillment
- Contributing to the further development of processes and organization of the Material Management department
Quality Expert for Weld Seam Inspection (m/f/d)
A leading automotive supplier is looking for an experienced quality expert to inspect weld seams on safety-relevant body components. The project involves ensuring the highest quality standards through non-destructive testing methods.
- Typical tasks: Independently plan, perform and evaluate non-destructive tests (NDT), especially visual testing (VT) and ultrasonic testing (UT). Create and manage test plans and work instructions. Detailed documentation of test results in CAQ systems. Analyze defect patterns and initiate corrective actions in close coordination with welding and production planning. Calibration and maintenance of test equipment.
- Relevant technologies/tools: Ultrasonic testing devices, 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-error tolerance for safety-critical seams (escape rate = 0), on-time completion of test orders.
- Key challenges: Assess complex seam geometries under time pressure. Clear interpretation of test results and distinguishing acceptable irregularities from critical defects. Enforcing quality standards with production.
- Deliverables: Completed test reports, detailed failure analyses and reports, updated work and test instructions, contributions to FMEAs (failure mode and effects analysis).
- Best practices: Regular team alignment (shopfloor management), continuous improvement of testing processes (CIP), raising awareness and training of production staff.
Freelance Clinical Data Manager (m/f/d)
On behalf of a renowned client in the life sciences sector, freelance support is sought in Clinical Data Management. The main task is to be responsible for coordinating all data management activities in clinical studies.
- 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 cycle.
- Development and execution of query processes to resolve data inconsistencies with study sites.
- Medical coding of adverse events (AEs) and medications (e.g., using MedDRA, WHODrug).
- Conducting SAE reconciliation (serious adverse event reconciliation).
- Preparation and execution of 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 languages/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 1000 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 working 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%.
- Specific challenges, risks or considerations:**
- Managing increasing data volumes and sources (e.g., wearables, ePROs).
- Ensuring data integrity and security (cybersecurity, data protection/GDPR).
- Complexity from mid-study changes (protocol amendments) and their impact on the database.
- Ensuring consistent data quality across multiple, globally distributed study sites.
- Lack of qualified specialists and high training demands for study-specific systems.
- 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 data set ready for statistical analysis.
- Final locked study database with complete audit trail.
- Archived project documentation after study completion.
QA Specialist – Digital Implementation
As part of a digitization initiative, software quality should 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 technical debt and vulnerability remediation.
- Training and support for developers in Clean Code, TDD, and CI/CD practices.
- Assessment and continuous improvement of QA processes, tools, and metrics.
New
Interim Procurement Professional (m/f/d)
- 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.
Customer Service Expert in the Energy Industry (m/f/d)
- Performing and handling change processes (supplier change, new registration, move-in/move-out)
- Independently handling clarification cases with analysis of rejection reasons and follow-up
- Supporting market communication and related areas (e.g., meter reading, billing) at least at 2nd-level
- Ensuring smooth workflows within energy industry processes
New
HSE Manager / Safety Specialist (m/f/d)
A company is looking for freelance support in the area of HSE management / safety specialist for a long-term project. The project's goal 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 trainings and audits, and creating and maintaining HSE reporting. The HSE Manager will work closely with clients, partners, and contractors to ensure compliance with safety standards.
Key responsibilities:
- Coordinate safety measures on the construction site according to Section 4 of the Occupational Safety Act
- Align and coordinate health and safety measures with contractors
- Maintain and update the HSE Site Manual
- Conduct toolbox talks
- Participate in coordination meetings
- Prepare and carry out trade-specific risk assessments
- Perform regular site inspections, including reporting and photo documentation
- Report and track defects and derive appropriate actions
- Conduct HSE trainings and briefings
- Monitor the use of personal protective equipment
- Organize and conduct HSE audits
- Create and maintain HSE reports
- Review relevant supplier documents
- Analyze work and near-miss incidents, including prevention measures
- Issue instructions to contractors on HSE-related matters
New
IT Project Manager Hospital Environment (m/f/d)
We are looking for an experienced IT project manager to lead and execute IT projects in a hospital setting. The goal is to deliver various digitalization and infrastructure projects (e.g. HIS migration, medical technology integration, ISMS implementation or TI components) on time, within budget and with assured quality.
In this role, the project manager takes full responsibility for planning, managing and executing the projects and acts as the link between IT, departments and management.
- Overall responsibility for planning, managing and executing IT projects in a clinical environment
- Coordination of internal and external stakeholders, including IT department, medical staff, service providers and manufacturers
- Ensuring adherence to time, budget and quality requirements
- Preparing project plans, status reports, decision documents and presentations
- Risk management, resource planning and escalation handling
- Managing acceptance and testing procedures, including documentation
- Supporting preparation for KHZG or NIS2 related measures
- Acting as interface between IT, departments and management
Interim Head of HR Country Services Germany, Austria (m/w/d)
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.
ABB Control System Specialist (m/f/d)
For a project in the power plant environment, a freelance specialist for migrating and adapting the ABB 800xA control system is needed 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 adaptation of controllers and I/O modules.
- Creation and adjustment of process graphics, operator interfaces and alarm management configurations.
- Execution of system tests, error analysis and performance optimizations to ensure plant availability and controllability.
- Technical support of operations staff during the commissioning and ramp-up phase.
- Preparation and maintenance of technical documentation (functional diagrams, configuration descriptions, test protocols).
- Close cooperation 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.
- Fieldbuses: 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 system components/functions migrated 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 staff on the new system environment.
- Key challenges, risks or specifics:**
- Migration in running 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 graphics 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 staff.
Tester for Subsea Cables (m/f/d)
A company is looking for an experienced tester for subsea cables with an electrical engineering or physics background. The project aims to advise and support cable tendering, cable qualification, and the definition and execution of tests during the project phase. The role includes working with bidders, defining requirements, and advising on test procedures to ensure the quality and functionality of the cables.
- Advice on cable tendering and qualification for the project phase
- Definition of requirements for manufacturing, interim storage, installation, completion, and testing
- Contract negotiations with bidders
- Definition of test requirements for all tests from type tests to Site Acceptance Tests (SAT)
- Advising on and defining test procedures: from production and FAT tests to type tests and Site Acceptance Tests
- Specific adaptation of test systems and methods for the project
TECH Senior Project Manager (m/f/d) (9685)
Project description
As part of the implementation and optimization of the **Multi Domain Orchestration and Inventory (MDOI)** tool in the mobile transport domain (B2X), the focus is on planning, setup, commissioning, management, and optimization of several thousand fixed and mobile network devices. The application allows the selection and configuration of suitable devices and technologies for their efficient use to achieve maximum network coverage and customer satisfaction. Efficiently managing these projects and processes while increasing automation requires the use of the MDOI software solution.
Description of services without personal reference
- **IT Project Management**: Creating software rollout and migration plans for the application's two-month releases of MDOI, based on Blueplanet, considering all relevant dependencies using JIRA and stakeholder management
- **Design Management**: Planning and creating all relevant designs, as well as reviewing them in the Multi Domain Orchestration and Inventory (MDOI) tool for the transport networks area, as an implementation description of the requirements using JIRA and Confluence
- **Stakeholder Management**: Developing and executing communication measures for software changes based on the created designs, checking whether the requirements are fully covered by the designs, including preparing documentation for management using Microsoft Outlook, Microsoft Teams, and JIRA
Interim Project Manager (m/f/d) for Healthcare Digitization
Managing a strategic digitization project in a hospital network, e.g. implementing a new HIS or an ePA in line with KHZG.
- **Typical responsibilities:**
- Overall responsibility for project planning, management and control (time, budget, quality).
- Managing the interdisciplinary project team.
- Requirements, risk and stakeholder management.
- Planning and managing 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 spec (Lastenheft), change concept, cutover plan, project closure report.
Specialist/Consultant in the Field of System Test Development for Special Machine Construction (m/w/d)
A company is looking for a specialist/consultant in the field of system testing development for special machine construction.
The System Test and Qualification group conducts system tests in development projects, including tests of individual components, machine modules and software releases. Responsibilities also include defining and executing acceptance tests.
The goal of the project is to support detailed planning of test tasks, creation and optimization of test case specifications and execution of integration and functional tests. Activities take place exclusively on site in the lab on machine systems.
- Detailed planning of test tasks
- Creation and optimization of test case specifications
- Execution of integration and functional tests
- Running test cases (black box, use case, fail case tests)
- Documenting and preparing test results in the test management tool and MS Office
- Error analysis and communication with developers (directly in the lab and via MS Teams)
- Coordination with project management and the test manager
Process and Consulting for Asset PnL (m/f/d)
We are looking for an experienced consultant for a process and project initiative in Asset P&L (Profit and Loss) at a leading international financial services provider.
- Typical responsibilities in this role:**
- Analyze and document the existing end-to-end P&L processes for various asset classes (e.g., equities, fixed income, derivatives).
- Identify weaknesses, risks, and inefficiencies in data collection, processing, and reporting.
- Design and develop optimized target processes for P&L calculation and attribution.
- Create functional specifications and business requirements for adapting or introducing IT systems (e.g., P&L engines, data warehouses).
- Manage the implementation of the new processes and tools, including milestone planning, stakeholder management, and test coordination.
- Develop controls to ensure data quality and consistency.
- Prepare training materials and conduct workshops for business areas (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 in P&L cycle time: target >25% efficiency gain.
- Decrease in manual correction entries: target >50% reduction through process automation.
- Data quality index: increase in first-time-right rate on data intake to >99%.
- Efficiency ratio (cost-to-income): demonstrate a positive impact on lowering the ratio.
- User adoption rate: acceptance of new processes/tools in the business area >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 areas (change management).
- Ensuring compliance with regulatory requirements (e.g., IFRS 9, BCBS 239).
- Time- and budget-critical implementation while ongoing operations.
- Concrete deliverables:**
- Milestone 1: completed as-is analysis and process documentation.
- Deliverable 1: detailed analysis report including risk assessment.
- 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.
Frontend developer to HR platform with Angular experience
Reach out to us if you are interested in working with us on the project.
Sign up to get access to more exciting projects that match your skills and preferences!
IMP Quality Manager (m/f/d)
Industry
Pharmaceutical
Area
Quality Assurance (QA)
Project info
- Period07.07.2025 - 07.10.2025
- Capacityfrom 90%
- Daily rate780 - 1060€
- LocationCologne, Germany
- Language
- German(Native)
- German
- Remote10 - 30%
Description
A large pharmaceutical company is looking for an IMP (Investigational Medicinal Product) Quality Manager to ensure GMP compliance and the quality of clinical trial materials.
Typical tasks in this role:**
Review and approval of manufacturing and batch records for drug substances and drug products.
Final quality release of clinical trial materials for use in studies.
Review and approval of GMP-related 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 questions and quality topics.
Planning and execution of internal audits and support during regulatory inspections and external audits.
Management and monitoring of CAPA actions 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 and 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 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 clinical phases.
Strict compliance with 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 ("Deliverables"):**
Released batches of clinical trial materials.
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.
Requirements
Must-Haves:**
Degree in a scientific field (pharmacy, chemistry, biology, biotechnology).
At least 5 years of experience in a GMP-regulated environment in the pharmaceutical industry (QA, QC, manufacturing).
Deep knowledge of cGMP requirements, especially for the manufacture and testing of (parenteral) clinical trial materials.
Experience in reviewing batch documentation and releasing pharmaceutical products.
Experience with quality systems (deviations, CAPA, change control).
Nice-to-Haves:**
Experience as a Qualified Person (QP) or equivalent qualification.
Certifications in quality management (e.g., DGQ/EOQ Quality Manager).
Experience with audits and regulatory inspections (e.g., Swissmedic, EMA, FDA).
Familiarity with Veeva Vault and SAP.
Personal qualities and mindset:**
Strong quality awareness and high attention to detail.
Excellent analytical skills and a structured, solution-oriented approach.
Outstanding communication and negotiation skills to liaise across departments.
Decisiveness and the ability to make sound risk assessments under pressure.
Team player with high self-responsibility and assertiveness.
English
Powered by FRATCH.IO GmbH