Monika Weber
Quality Specialist
Experience
Quality Specialist
Nexans GmbH
- Implementation of a quality management system including creating all required process descriptions and work instructions for ISO 9001:2015 certification, as well as final planning and conducting audits
- Creating action catalogs for measures needed to comply with ISO 9001 and achieve the targeted certification
- Preparing documentation related to ISO 9001
- Developing training materials for employees and managers based on the QMH and the created documentation
- Recording results of external audits of departments (incoming goods, production, warehouse logistics, procurement and supplier management, outgoing goods, shipping) according to ISO 9001
- Preparing for and participating in certification audits
Project Manager in Medical Devices
Merz Aesthetics GmbH
- Leading the FDA pre-approval readiness
- Defining work packages
- Creating, reviewing, maintaining and updating GCP-related guidelines and other quality documents
- Developing a new issue management and an EM monitoring process
- Serving as a contact for questions about CAPAs, audits, deviations, SOPs and risk analyses
- Supporting change management, complaint handling and issue management
- Conducting trainings
- Assisting departments with audits and inspections
- Collaborating across departments
Consultant in Change Management
B.Braun Melsungen Aktiengesellschaft
- Handling change requests in the electronic change control system
- Processing changes in the electronic change control system
- Creating reports for R&D change management in the electronic change control system
- Supporting project management
- Organizing change control processing
- Coordinating change control including progress tracking and task tracking in the electronic change control system
- Planning and conducting kick-off meetings
- Preparing memo-to-files
- Reviewing reports
- Coordinating and tracking MDR-related changes
Interim Quality Manager
Calibre Scientific GmbH / Biozol
- Implementing a quality management system including creating all required process descriptions, work instructions etc. for medical devices in cell technology and various laboratory products for ISO 13485 certification, as well as final planning and conducting audits for ISO 13485, the Medical Device Regulation (MDR) and IVDR (EU 2017/746)
- Creating action catalogs for measures needed to comply with ISO 13485, MDR and IVDR (EU 2017/746) and achieve the desired certification
- Preparing documentation for ISO 13485 and MDR
- Reviewing existing quality agreements with suppliers and updating them as needed
- Conducting supplier audits for ISO 13485
- Developing training materials for employees and managers based on the created quality management manuals and documentation
- Recording results of external audits of departments (incoming goods, production, warehouse logistics, procurement and supplier management, outgoing goods, shipping) for ISO 13485 and MDR
- Preparing technical documentation
- Monitoring the safety profile of medical devices and test products
- Medical/pharmacological evaluation of individual cases including trend analysis and risk assessment
- Conducting PMCF tests
- Initiating CAPAs and/or updating risk analyses and IFUs based on data analysis
- Reporting to authorities and notified bodies
- Compiling safety-related information and reports for medical devices (post-market surveillance reports, post-clinical follow-up reports, short reports on safety and performance)
- Monitoring the market according to ISO 14971, ISO 13485, EU 2017/745 and EU 2017/746
- Supporting clinical trials and assisting the development team in preparing documentation
- Assisting with regulatory submissions and life-cycle management for medical devices and in applying for/renewing CE marking
- Providing expertise in coding for MedDRA/IMDRF
- Preparing for and participating in MDV audits and inspections, as well as ISO 13485:2021-12 and MDSAP audits
Consultant
Inosolve Consulting GmbH
- Advising on creating product quality reviews for solids and liquids
- Reviewing product quality reviews
- Assisting in preparing product quality reviews
- Helping collect IPK data and create graphs
- Supporting the preparation of stability reports
GMP Expert
Levano Med GmbH
- Review of existing SOPs
- Consultation on required SOPs
- Revision of the QMH / SMF
- Consolidation of documentation
- Review of documentation according to regulatory requirements for solids and liquids
Senior CV Specialist
Miltenyi Biotec B.V. & Co.KG
- Planning and execution of CSV with the aim of fully completed validation documentation for IT systems, complying with ISO 13485, 21 CFR 820, 21 CFR Part 11
- Creating an as-is analysis of existing CSV using SharePoint
- Planning and execution of CSV in the SAP environment
- Preparing monthly project reports and presentations with MS Project
- Reviewing validations considering ISO 13485, FDA requirements and GMP
- Creating complete validation documentation
- Assisting in preparing validation documents for various SAP projects
- Creating a work instruction and training presentation for SAP CSV
- Creating complete validation documentation for SAP BAS
- Developing an SOP for User Authorization and Security Concept for SAP
- Supporting the development of a concept for digitizing SAP CSV
- Supporting the development of a validation concept adapted to the needs of SAP CSV
- Performing risk analyses and creating a traceability matrix
- Conducting status meetings in the SAP CSV area
- Developing the new validation process for SAP CSV, including the SOP, work instruction, Good Documentation Practice and training documentation, as well as revising all existing validation documents to prepare for migration to the new digitization tool for SAP CSV
- NC/CAPA management
- Root cause analyses
- KPI tracking / reporting
- Implementing improvements / corrective actions
Interim Quality Manager
Biobedded Systems GmbH
- DIN EN ISO13485:2021 - adapting QM systems to an expanded team structure
- Adapting and harmonizing core QMS processes to ensure or improve quality and process stability
- Creating and revising quality management processes
- Managing process owner activities to ensure process compliance
- Standardizing and digitizing processes to increase efficiency
- Reviewing, controlling and optimizing workflows in Confluence
- Preparing training documentation and conducting training sessions
- Preparing/updating project documentation for annual audits (Jira / Confluence)
- Supporting test engineers in app validation
- QM representative
- Consulting and support in the field of CSV
- Compliance management
- Risk management
- Preparing technical documentation
- Usability and user experience processes according to IEC 62366-1
- Ensuring compliance with DIN EN ISO 62304 and DIN EN ISO 14971
- Creating a quality management manual
- ISO 13485:2021 including MDR requirements
- Developing standard operating procedures and work instructions
- Implementing QM guidelines into practical processes
- Developing and implementing QM-oriented project management processes
- CAPA management
- Consulting on MDR, ISO 13485, Medical Devices Act (MPG) standards
- Adapting existing and developing new procedures and work instructions
- Contributing to the creation and implementation of changes
- Developing processes to ensure quality requirements
- Developing processes to ensure process compliance, reviewing all development activities for quality criteria, checking interfaces for quality criteria and further development if necessary
- Performing risk analyses
- Computer system validation
Auditor
Freelance
- Internal and supplier audits
- Medical technology ISO 13485, Medical Devices Act (MPG), MDR, MDD, ISO 14971, DIN EN ISO 62304
- Pharmaceutical industry GMP, GDP, GLP, GxP, etc.
- Chemical industry ISO 9001
Senior CSV Specialist
Richard Wolf GmbH
- Validation lead – reviewing and approving validation documents
- Ensuring compliance with ISO 13485, MPG and MDR, consulting and supporting the creation of technical documentation
- Compliance management, risk management
- Change management including release planning
- Planning and implementing new SAP modules with creation and execution of computer system validation
- Conducting risk analyses according to ISO 14971
- Ensuring compliance with DIN ISO 62304
- Planning and conducting computer system validations according to GAMP 5, GxP
- Preparing project reports and presentations
- Creating process descriptions for IT GAP analyses, risk analyses
- Conducting training sessions
- Leading validation projects
- Supporting the development of processes to ensure quality requirements in the development area
Auditor
Freelance
- Internal and supplier audits
- Medical devices ISO 13485, MPG, MDR, MDD, ISO 14971
- Pharmaceutical industry GMP, GDP, GLP, GXP etc.
- Chemical industry ISO 9001
Document Specialist
Pharma / anonymous client
- Creation and execution of CSV
- Compliance management, risk management
- Adapting and harmonizing core QMS processes to ensure or improve quality and process stability
- Creating and revising quality management processes
- Managing process owners' activities to ensure process compliance
- Standardizing and digitizing processes to increase effectiveness
- Revising, reviewing and optimizing workflows in Confluence
- Preparing training documentation and conducting trainings
- Preparing/maintaining project documentation for annual audits (Jira / Confluence)
- Creating complete documentation for process validation for solid production
- GAP analysis of existing validation documentation
- Process and cleanroom validation, development validation for solid production, revalidation
- Creating and editing batch record reviews
- Creating and revising manufacturing instructions
- Creating and updating SOPs, forms, and change requests (CCR)
- Supporting maintenance of GMP status in pharmaceutical manufacturing (deviations, error investigation reports)
- Conducting CAPA processes, logging CAPAs, change control
- Conducting risk analyses
- Employee training
- Audit preparation for an FDA audit
Change Control Consultant
Pharma / anonymous client
- CAPA management, root cause analyses
- Compliance management; KPI tracking/reporting
- Risk management
- Coordination and monitoring of change controls (German and/or English)
- Matching and updating documents in line with approvals
- Assigning necessary activities for the respective changes
- Ensuring timely processing of changes
Interim Quality Manager
Medical device / anonymous client
- Consulting and support in CSV
- Compliance management, risk management
- Creating technical documentation
- Adapting and harmonizing core QMS processes to ensure or improve quality and process stability
- Creating and revising quality management processes
- Managing activities of process owners to ensure process compliance
- Standardizing and digitizing processes to improve effectiveness
- Revising, reviewing and optimizing workflows in Confluence
- Preparing training documentation and conducting trainings
- Preparing/maintaining project documentation for annual audits (Jira / Confluence)
- Usability processes according to IEC 62366-1
- Preparation for ISO 9001:2015 recertification
- Creating a quality management manual according to ISO 9001:2015 and ISO 13485
- Conducting internal audits including reporting and follow-up
- CAPA management
- Advice on MDD, ISO 13485, MPG standards
- Updating existing SOPs and creating new ones
- Supporting the ISO 9001:2015 certification audit
- Contributing to creation and implementation of changes
- Developing processes to ensure quality requirements
- Developing processes to ensure process compliance; reviewing all development activities against quality criteria, checking interfaces for quality criteria and further development if needed
- Creating risk analyses
- NC/CAPA management, root cause analyses
- KPI tracking/reporting
- Implementing improvements/corrective actions
Regulatory Affairs Consultant
Pharma / anonymous client
- Creating validation documentation
- Compliance management, risk management
- Providing expert advice to project teams in meetings on regulatory requirements and FDA and other authorities’ requirements
- Adapting and harmonizing core QMS processes to ensure or improve quality and process stability
- Creating and revising quality management processes
- Managing activities of process owners to ensure process compliance
- Standardizing and digitizing processes to increase effectiveness
- Revising, reviewing and optimizing workflows in the QMS system
- NC/CAPA management, root cause analyses
- KPI tracking/reporting
- Implementing improvements/corrective actions
- Preparing training documentation and conducting trainings
- Preparing/maintaining project documentation for annual audits (Jira / Confluence)
- Preparing and supporting an FDA audit
- Commissioning the creation of quality documents
- Coordinating creation of quality documents by departments
- Reviewing quality documents
- Creating regulatory documents according to relevant guidelines
- Creating and implementing changes
- Creating a user manual for the new SAP BI modules in BEX Analyzer
Audit Assistant
Freelance
- Conducting various audits as an Audit Assistant APEX, IECex, ISO 9001:2008
Quality Management Consultant
Pharma / Anonymous Client
- GAP analysis regarding GMP-compliant archiving of all documentation
- Compliance management, NC/CAPA management
- Risk management, root cause analyses
- Adapting and harmonizing key QMS processes to ensure or improve quality and process stability
- Creating and revising quality management processes, KPI tracking/reporting
- Managing process owner activities to ensure compliance with processes
- Standardizing and digitizing processes to increase effectiveness
- Reviewing, controlling and optimizing workflows in the QMS system
- Creating training documentation and conducting training sessions
- Preparing/updating project documentation
- Providing professional advice to project teams in project meetings regarding regulatory requirements and authority demands (EMA, FDA, LAGeSo)
- Preparing and supporting FDA and LAGeSo authority audits
- Regulatory evaluation of change-control requests in the change control system with regard to relevant SOPs
- Performing computer system validations
- Coordinating the creation of quality documents by departments
- Reviewing quality documents
- Drafting regulatory documents according to relevant guidelines
- Qualifying and validating laboratory equipment
- Reviewing test method validations
- Participating in the creation and implementation of changes
- Advising on APQR and change control
- Building or adapting the QMS system
- Supporting official GMP inspections
- Conducting internal audits (self-inspections)
- CAPA management
- Qualifying the supply chain and coordinating audits
- Supporting the integration and compliance of GMP requirements and proof during inspections
- Advising on GMP, GDP, GLP, MPG
- GAP analysis; creating a remediation plan
- Risk management & FMEAs; compliance checks
Quality Manager Operations
Honeywell Seelze GmbH
- Responsible for implementing the quality strategy in the supply chain area (logistics and packaging)
- Compliance management, risk management
- Responsible for implementing the quality strategy for the luminescent pigments area and the entire logistics department
- Adapting and harmonizing key QMS processes to ensure or improve quality and process stability
- Creating and updating quality management processes
- Managing process owner activities to ensure process compliance
- Standardizing and digitizing processes to boost effectiveness
- Creating training documentation and conducting training
- Reviewing documents in quality assurance
- Supporting CAPA tracking
- Supplier qualification and management
- Supporting change control
- Assisting with logbook reviews
- Supporting deviation handling
- NC/CAPA management, root cause analyses
- Preparing and supporting an FDA audit
- Implementing QM measures and further developing the integrated QM system considering requirements from DIN EN ISO 9001, GMP, MPG, and other standards and regulations
- Enhancing and improving quality processes
- Collaborating in (or initiating), assessing, and approving deviation investigations
- Stopping production when quality risk is imminent
- Providing GMP support in evaluating safety information
- Providing professional advice to project teams in project meetings on regulatory requirements and authority demands (EMA, FDA, LAGESO)
- Regulatory evaluation of change-control requests in the change control system according to relevant SOPs
- Commissioning the creation of quality documents
- Coordinating the creation of quality documents by departments
Quality Management Representative
Eckert & Ziegler Strahlen und Medizintechnik AG; Eckert & Ziegler Nuclitec GmbH; Eckert & Ziegler Umweltdienste GmbH
- Implementing quality measures and contributing to the development of the integrated QMS (ISO 9001, ISO 13485, KTA, GMP, GDP, GLP)
- NC/CAPA management, root cause analyses
- Supporting quality assurance tasks in other departments
- Facilitating working groups
- Process documentation, KPI tracking, and reporting
- Conducting internal and supplier audits and reporting
- Planning and delivering quality management training
- Feasibility and failure analyses
- Defining measures for continuous improvement
- Preparing and supporting the ISO certification audit
- Handling approval applications (Class II, Class III)
- Adapting and harmonizing key QMS processes to improve quality and process stability
- Creating and updating quality management processes
- Managing process owner activities to ensure process compliance
- Standardizing and digitizing processes to enhance effectiveness
- Creating training documentation and conducting training
- Preparing/updating documentation for annual audits
Project Management Assistant
Randstadt
- Attending and conducting meetings, implementing resulting actions
- Coordinating and taking responsibility for projects
- Organizing coordination processes inside and outside the company
- Reviewing and processing contracts regarding business and legal aspects
- Scheduling and organizing appointments
- Following up on meetings and recording minutes
- Supporting project managers with organizational and administrative tasks
- Maintaining and ensuring data quality
- Building and updating the project data base (organization charts, presentations)
- Ensuring the formal accuracy of project documentation
- Managing information distribution and reporting (project plans, status reports)
- Creating and maintaining effort and timeline plans and related reports
- Preparing materials for steering committees
- Project controlling
- Requesting, managing, and verifying timesheets
- Maintaining the resource overview (plan vs. actual comparison)
- Monitoring and updating the project risk log
- Managing and tracking the open issues list (attendance list, notifications, contracts)
Quality Management Assistant
Med-X-Press GmbH
- CSV: Validating the company's entire computer system under GAMP and other regulations
- Compliance management, NC/CAPA management
- Risk management, root cause analyses
- KPI tracking and reporting
- Reviewing documents in quality assurance
- Assisting with tracking CAPAs
- Assisting with reviewing logbooks
- Assisting with handling deviations
- Creating, revising, and implementing SOPs
- Preventive measures and immediate corrections
- Implementing QM measures and helping develop the integrated QM system considering requirements from DIN EN ISO 9001, GMP, GAMP, 2001/83/EC, Regulation EC 178/2002, ISO 17025, MPG
- Developing and improving quality processes
- Training on QM regulations and other quality topics
- Handling complaints (8D report)
- Risk analyses
- Ensuring packaging of pharmaceutical products in terms of quality, timing, cost, and resources
- Handling deviations, complaints, and OOS for the packaging area
Marketing, Sales and Project Management Assistant
Med-X-Press GmbH
- Attending and conducting meetings, implementing follow-up actions
- Coordinating and taking responsibility for projects
- Designing the ERP system with external developers
- Organizing coordination processes within and outside the company
- Reviewing and handling contracts regarding business and legal aspects
- Coordinating and organizing appointments
- Following up on meetings and taking minutes
- Supporting project leads with organizational and administrative tasks
- Maintaining and ensuring quality of data management
- Setting up and updating the project database (organization charts, presentations)
- Ensuring the formal accuracy of project documentation
- Distributing information and reporting (project plans, status reports)
- Creating and maintaining effort and schedule plans and related reports
- Preparing documents for steering committees
- Project controlling
- Requesting, managing, and verifying timesheets
- Maintaining resource overview (plan vs. actual)
- Monitoring and maintaining the project risk list
- Managing and tracking the open items list (attendance list, notifications, contracts)
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Healthcare (8 years), Pharmaceutical (3 years), Biotechnology (2 years), Manufacturing (1.5 years), Chemical (1.5 years), and Professional Services (0.5 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Quality Assurance (10.5 years), Project Management (7 years), Information Technology (2 years), Operations (2 years), Supply Chain Management (1 year), and Audit (0.5 years).
Summary
Quality manager with leadership experience specializing in medical technology, pharmaceutical and chemical industries. I support pharmaceutical companies, medical device manufacturers, chemical companies and food businesses in meeting regulatory requirements such as GxP, GLP, GDP, GMP, ISO 13485, ISO 9001, IFS, BRCGS, FSSC 22000, ISO 22000, IVDR 2017/746 and MDR.
Furthermore, I offer all the professional and methodological skills needed to establish and improve quality management systems, as well as process and project management, and as a Senior CSV expert in validation projects as a Validation Lead or Validation Coordinator.
Skills
Core Competencies
- Quality And Compliance Management
- Audits And Training
- Regulatory Affairs
- Change Management
- Capa Management
Skills
- Project Management
- Technical Documentation
- Process Management
- Document Management
- Capa Management
- Audits
Standards Focus
- Mdr, Ivdr 2017/746
- Iso 13485, Iso 9001, 21 Cfr Part 11, Eu Gmp Guidelines, 21 Cfr Part 820
- Iec 62366-1, Iec 60601-1, Iec 62304
- Iso 14971, Iec 62366
- Iso 17025, Gxp, Amwhv, Gcp, Cgmp, Glp, Gdp, Amg, Fda Guidelines, Ich Standards
- Ifs, Brcgs, Fssc 22000, Iso 22000
- And Other Standards And Regulations
Software
- Ms Office, Incl. Visio And Project (Very Good Knowledge)
- Jira (Good Knowledge)
- Sap (Good Knowledge)
- 4pep (Good Knowledge)
- Sap Ehsm Prc (Good Knowledge)
- Tempestiva (Good Knowledge)
- Dms Systems (Very Good Knowledge)
- Confluence (Very Good Knowledge)
- Conactiv (Good Knowledge)
- Kneat (Good Knowledge)
- Valgenesis (Good Knowledge)
- Sharepoint (Good Knowledge)
- Valgeneis (Very Good Knowledge)
Languages
Education
Private Naturopath School
Training as a naturopath
Inlingua Language School
Foreign language correspondent
Private Massage School of the Brothers Hospitallers
Masseuse and medical bath therapist, medical pedicurist
Certifications & licenses
Re-certification as Quality Management Representative including TQM ISO 9001:2015
QMB Food – representative for food safety and quality
GMP Auditor (officially recognized)
GMP Expert
Quality Management Representative ISO 13485:2016
Lead Auditor in Quality Management IRCA
Trainer in quality and project management including project leadership
Certification as Quality Management Representative including TQM ISO 9001:2008
Profile
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