Portfolio
Quality Assurance
- Implementation of quality systems
- Optimisation of quality systems
- Assessing quality systems or parts of systems for compliance with laws and regulations
- Analysing and optimising of processes for effectiveness and efficiency
- Reorganisation of quality systems, e.g., for expansion, harmonisation, or refocusing
- Preparation and facilitation of risk assessments
I can assist with the development of processes, project management during implementation and the preparation of standard documents / work instructions / SOPs and the training of staff.
Quality Control
- Preparation or review of documentation
- Assessment of data for process evaluation or control
- Evaluation of process and analytical data for preparation and execution of PPQs
- Optimisation of manufacturing processes
- Identification and mitigation of weaknesses or problems
- Preparation of documents for qualification or transfer of processes
Manufacturing
- Preparation or review of documentation
- Assessment of data for process evaluation or control
- Evaluation of process and analytical data for preparation and execution of PPQs
- Optimisation of manufacturing processes
- Identification and mitigation of weaknesses or problems
- Preparation of documents for qualification or transfer of processes
Analytical method validation
- Design of method validation according to ICH Q2(R2), also for bioanalytical methods
- Preparation or review of validation protocols and reports
- Performance of statistical analysis
- Support in the determination and evaluation of key figures
- Troubleshooting if predefined criteria are not met
Analytical method transfer
- Preparation or review of transfer protocols and reports
- Conduct of gap analysis
- Management of method transfers
- Troubleshooting if predefined criteria are not met
Changes, Deviations/CAPA, Complaints, Out of Specification (OOS)
- Change introduction and implementation
- Handling deviations and CAPAs
- Complaint handling
- Defining acceptance criteria/system suitability criteria and specifications
- Processing of OOS results
Document preparation and review
Preparation, review and revision of documentation in quality assurance, quality control or manufacturing, e.g.
- Test instructions
- Test reports and CoA
- Master batch records
- Executed batch records
- Qualification documentation
- Validation documentation
- Risk analyses
Equipment Qualification, Computer Validation
- Performance of equipment qualifications and validations of computerised systems, especially for quality control
- Preparation or review of documentation for qualification and validation as well as for operation and maintenance
- Preparation and validation of Excel spreadsheets
Supplier selection and qualification
- Supplier selection, especially for quality control
- Qualification of suppliers of raw materials, starting materials, for quality control, manufacturing or services
- Performance of audits
- Preparation, revision or review of quality agreements
Quality Agreements
- Preparation, revision or review of quality agreements for quality control, manufacturing or services
- Negotiation of agreements
Risk Analyses
- Preparation risk assessments for, e.g.:
- Qualification of equipment or computerised systems
- Analytical methods, e.g., for preparation of validation, excursions in routine operations
- Issues or excursions in manufacturing
- Issues with supply of materials or services
- Facilitating preparation of risk assessments
Education and Training
I would be happy to conduct training courses on site, e.g.:
- GLP or GMP basics
- Change Control, Deviation Control, CAPA, OOS, Complaints
- Documentation in the GLP and GMP environment
- Costumer audits
- Inspections by European and US authorities
- Validation of (bio)analytical methods.
All training is prepared individually. Exercises and practical application are emphasised. Success controls are carried out on request.
Audits and Inpections
I have extensive experience in the role of auditee and auditor in an international environment, in both German and English. I would be happy to assist you with
- Preparation, organisation, support and follow-up of client audits or regulatory inspections
- Training in preparation for audits and inspections
- Carrying out pre-inspections including preparation of action plans
- Conduct mock inspections (English/German)
- Performance of (self)inspections
- Supplier audits for GLP, GMP, ISO 9001, 13485 etc.
Project Management
I would be happy to support your projects with
- Preparation of project plans
- Monitoring project progress
- Adapting project plans
- Reporting on project progress
Interim Activity
Contact me if a role is temporary, or if positions cannot be filled or re-filled within the desired timeframe. I am happy to take on interim roles in quality management and quality control. You will benefit from my many years of experience in the quality management of a service provider for the quality control of pharmaceutical, in particular biopharmaceutical products for international clients as well as additionally from several projects as a freelancer.