Ricarda Mayer
Consultant Quality Management
Experience
Consultant Quality Management
Quality for Life Sciences (Consulting)
- Quality assurance / management
- Process optimization (laboratory processes, QM/QS processes, etc.)
- Revision and adaptation of existing systems (e.g. document management, equipment management) to ensure compliance with new regulatory requirements
- Implementation/optimization of deviation and/or change control management processes
- GLP and GMP support
- Interim Quality Manager
- QA management
- Audits and inspections
- Conducting internal audits / self-inspections (GLP, GMP)
- Organization, preparation, coordination and support of regulatory inspections including creation of action plans if needed
- Creation and revision of controlled documents (SOPs, qualification documents, manufacturing instructions, checklists, forms, etc.)
- Content review of existing controlled documents for compliance, structure/format and consistency
- "Streamlining" of document management systems
- Basic training (GLP, GMP)
- Refresher training (GLP, GMP)
- Equipment qualifications
- Other topics on request
Compliance Senior Manager
Amgen Research (Munich) GmbH
- Personnel responsibility for two employees
- Responsibility for all regulatory compliance issues at local and global levels
- Deputy for QA in the area of GLP and GCP at the site
- Organization, coordination and lead oversight of regulatory inspections
- Creation, maintenance and management of the qualification and validation master plan, including support and organization of equipment management (equipment qualification and CSV)
- Responsible for deviation and change control management
- Creation and review of controlled documents
- Development and delivery of GxP-relevant training
- Implementation of the qualification and validation program
- Harmonization of existing and new global QA processes
Associate Director, QA
Micromet AG
- Personnel responsibility for one employee
- Responsible for GMP QA and deputy for GLP QA
- Organization, coordination and lead oversight of audits and inspections by authorities and external customers
- Review of batch manufacturing documents in collaboration with CMC and the Qualified Person, as well as organization and management of the release process for clinical material
- Consulting and support for equipment qualifications
- Processing, maintenance and monitoring of the deviation and change control system
- Creation and review of controlled documents
- Conducting GxP and QA-related training
- Conducting internal and supplier audits
- Project lead for ceasing GMP activities at the site, including return of manufacturing license and GMP certificate
- Implementation of new QA processes as part of the harmonization "Amgen Inc. - Amgen Research (Munich) GmbH"
Manager QA GMP
Micromet AG
- Personnel responsibility for one employee
- Responsible for GMP QA and deputy for GLP QA
- Organization, coordination and lead oversight of audits and inspections by authorities and external customers
- Review of batch manufacturing documents in collaboration with CMC and the Qualified Person, as well as organization and management of the release process for clinical material
- Consulting and support for equipment qualifications
- Processing, maintenance and monitoring of the deviation and change control system
- Creation and review of controlled documents
- Conducting GxP and QA-related training
- Conducting internal and supplier audits
Manager QA
Medigene AG
- Review of batch manufacturing documents for drug release by the Qualified Person according to the AMWHV
- Point of contact for questions and implementation of GMP and quality-related measures
- Oversight of equipment qualification activities and review of qualification documents
- Management of technical changes to qualified systems ("Technical Change Control")
- Processing of regulatory changes in coordination with the Regulatory Affairs department
- Handling deviations
- Creation and review of controlled documents
- Conducting QA and GMP training for employees
- Organization and execution of self-inspections
- Introduction of trend analysis for manufacturing and analytical quality
- Conceptual redesign of the DMS
Manager QA (Head of QA Department)
IDEA AG
Associate Manager QA
IDEA AG
Research Associate QA
IDEA AG
Assistant of Head of QA
IDEA AG
Working Student
IDEA AG
Industry Experience
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Experienced in Biotechnology, Pharmaceutical, and Information Technology.
Business Area Experience
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Experienced in Quality Assurance, Research and Development, and Project Management.
Summary
As an experienced certified quality manager in the pharmaceutical environment, I have excellent quality awareness and understanding, as well as strong organizational skills. Proactive communication, empathetic leadership and a strategic focus allow me to lead teams in a goal-oriented and inclusive way.
By clearly prioritizing projects, managing resources efficiently and planning ahead, I meet the company's time and objectives.
My career has been shaped by successfully organizing, coordinating and overseeing regulatory inspections and customer audits.
Skills
- Quality Assurance / Management
- Process Optimization (Laboratory Processes, Qm/qs Processes, Etc.)
- Revision And Adaptation Of Existing Systems (E.g. Document Management, Equipment Management) To Ensure Compliance With New Regulatory Requirements
- Implementation/optimization Of Deviation And/or Change Control Management Processes
- Glp And Gmp Support
- Interim Quality Manager
- Qa Management
- Conducting Internal Audits / Self-inspections (Glp, Gmp)
- Organization, Preparation, Coordination And Support Of Regulatory Inspections Including Creation Of Action Plans If Needed
- Creation And Revision Of Controlled Documents (Sops, Qualification Documents, Manufacturing Instructions, Checklists, Forms, Etc.)
- Content Review Of Existing Controlled Documents For Compliance, Structure/format And Consistency
- "Streamlining" Of Document Management Systems
- Basic Training (Glp, Gmp)
- Refresher Training (Glp, Gmp)
- Equipment Qualifications
- Other Topics On Request
Hard Skills
- Change Control Management And Deviation Management
- Project Management
- Design And Management Of Qualification/validation Programs
Soft Skills
- Agile And Entrepreneurial Mindset
- Appreciative Leadership
- Strong Team Spirit
- Conflict Management And Mediation
It Knowledge
- Ms Office
- Iwork
- Dms Veeva Vault (Cloud-based)
- Elpro Monitoring System
- Chatgpt, Perplexity, Mistral
- Sap
Languages
Education
Fachhochschule Weihenstephan
Biotechnology · Freising, Germany
Ludwig-Maximilians-Universität
Chemistry · Munich, Germany
Luitpold-Gymnasium
High School Diploma · Munich, Germany
Certifications & licenses
Six Sigma Green Belt
Q-Learning
Lean Master
Q-Learning
Custom GPTs: Creating your own GPTs for QM
DGQ
Using generative AI in QM
MQ GmbH
Quality @Generative AI
Mehr.Wert Qualitätslösungen
ISO 13485:2016 - Introduction and implementation
TÜV
ISO 14001 – Environmental management systems
TÜV
DGQ Quality Auditor
DGQ Quality Manager
DGQ Quality Representative and Internal Auditor
DGQ
Statistics
Experience
Global Experience
Expertise
Qualifications
Profile
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