Project Overview

Audits and Inspections

Preclinical services, virus validation studies

Subsidiary of a global pharmaceutical company, Vienna, Austria

• Internal inspections and international supplier audits

Interim Head of Quality Control and Head of Quality Assurance

Contract manufacturing, APIs (biopharmaceuticals) and cell lines: antibodies, enzymes, mammalian and moss cells, parenterals, preclinical and clinical phases

GMP and GLP, EU regulations

Small biopharmaceutical company, Bielefeld and Hamburg, Germany

• Maintenance and further development of the quality assurance system including preparation, review and approval of SOPs
• Establishment and implementation of a GLP system
• Review, preparation and approval of changes and deviations
• Review, preparation and approval of equipment qualification and calibration documentation, including computerised systems
• Review and approval of master batch records
• Review of executed batch records and preparation of batch release 
• Preparation, performance and follow up of regulatory and customer audits
• Preparation and approval of quality agreements with customers and subcontractors
• Induction and training of personnel, conducting training courses, onboarding
• Review and approval of test instructions
• Preparation and approval of analytical method validation protocols, data evaluation, preparation and approval of reports
• Establishment and qualification of reference substances for the individual projects
• Definition of specifications
• Qualification and release of raw materials
• Support of stability studies, statistical evaluation of data and preparation of reports
• Performance of OOS procedures
• Development and supervision of hygiene programme and environmental monitoring
• Support for preparation and updating of Investigational Medicinal Product Dossier (IMPD)
• Project management, e.g. for the set-up and relocation of manufacturing sites

Project Manager Consumer Healthcare Products

Consumer Healthcare Products (small molecules, natural products and extracts, vitamins): soft gelatine capsules, tablets, syrups; manufacturing, control and packaging

GMP and food regulations, EU and national requirements

German subsidiary of a global pharmaceutical company, near Frankfurt, Germany

• Project leader for remediation, optimisation and validation of analytical test methods at subcontractors (EU region)
• Preparation analytical method validation protocols, data evaluation, report writing
• Project leader for transfer of analytical methods to subcontractors (e.g., Switzerland, Argentina, Mexico)
• Preparation of protocols for analytical method transfers, data evaluation, preparation of reports
• Preparation of protocols for initial or ongoing stability studies, data evaluation, preparation of reports
• Evaluation of process and analytical data for preparation and execution of PPQs
• Preparation, updating and review of CMC documentation
• Support of manufacturing process optimisation
• Process transfer support
• Troubleshooting in manufacturing, QC and packaging

Manufacturing Science & Technology Consumer Healthcare Products

Consumer healthcare products (small molecules, natural products and extracts, vitamins): soft gelatine capsules, tablets, syrups

GMP, EU regulations and national requirements 

Headquarters of a global pharmaceutical company, near Mainz, Germany

• Performance of Continuous Process Verifications (CPV)
• Preparation and evaluation of stability studies
• Troubleshooting and optimisation of analytical methods

FDA inspection, preparation, support, and follow-up

Contract laboratory, analytical services (small molecules, natural products and extracts)

GMP, US FDA regulations (21CFR 210 and 211)

Medium-sized pharmaceutical company, near Nuremberg, Germany

• Documentation review (i.e., SOPs, test instructions and analytical method validations, stability studies, changes, deviations, OOS)
• Performance of gap assessment
• Audit organisation 
• Conduct follow-up activities

Third Party Quality Manager Consumer Healthcare Products

Consumer healthcare products (small molecules, natural products and extracts, vitamins): soft gelatine capsules, tablets, syrups

GMP, EU regulations and national requirements

Headquarters of a global pharmaceutical company, near Mainz, Germany

• Product design reviews
• Performance of Continuous Process Verifications (CPV)
• Stability study preparation and evaluation
• Support to quality managers

Deputy Head Quality Assurance

Pharmaceuticals and APIs (small molecules, narcotics, hormones): tablets, liquids, sprays, transdermal applications

GMP, EU regulations

Medium-sized pharmaceutical company, Berlin, Germany

• Monitoring of manufacturers
• Review of CMC documentation
• Performance of supplier audits
• Review of supplier agreements
• Optimisation of quality processes, preparation and review of SOPs

GLP System implementation

Contract testing, bioanalytical methods, preclinical phase

GLP, EU regulations and national requirements

Small biopharmaceutical company, Bielefeld, Germany

• Preparation project plan including required resources, procedures, equipment and material
• Writing of SOPs and related changes
• Training of personnel
• Updating of existing procedures
• Preparation, performance and follow-up of regulatory inspections
• Optimisation of analytical method
• Preparation of validation protocol, statistical evaluation of data, writing of report
• Review of study protocols, raw data and reports

Interim Head of Quality Assurance and Head of Process Quality

Active pharmaceutical ingredient (biopharmaceutical): vaccine, parenteral, clinical phase III, 

GMP, EU and US FDA (21CFR 210 and 211) regulations

Subsidiary of a medium-sized US biopharmaceutical company, near Düsseldorf, Germany

• Evaluation and optimisation of quality processes
• Deviation, change and CAPA management
• Preparation and review of SOPs
• Process and quality data analysis and reporting

FDA inspection, preparation and support

Contract Manufacturing, APIs (biopharmaceuticals)

GMP, US FDA regulation (21CFR 210 and 211)

Medium-sized pharmaceutical company, near Kiel, Germany

• Documentation review
• Performance of gap assessment
• Back-office management

FDA inspection, preparation and support

Contract laboratory, analytical services (small molecules, natural products and extracts)

GMP for food and dietary supplements, US FDA regulations (21CFR 110 and 111)

Medium-sized pharmaceutical company, near Nuremberg, Germany

• Documentation review
• Performance of gap assessment
• Back-office management

Lectures University

University of Applied Sciences, Biotechnological Instrumentation Engineering, Bielefeld, Germany

• Virus validation studies
• GMP
• Risk Management

Interim Manager Quality Management Systems

Pharmaceuticals and medical devices (infusion fluids and concentrates)

ISO 13485, EU regulations

Medium-sized subsidiary of a global medical device and pharmaceutical company, near Osnabrück, Germany

• Remediation activities in manufacturing and quality control
• Preparation and revision of SOPs
• Review of analytical method validation documentation
• Establishment and optimisation of processes and systems 
• Root cause analyses in production

FDA inspection, preparation and support

Contract laboratory, analytical services (small molecules, natural products and extracts)

GMP, US FDA regulations (21CFR 210 and 211)

Medium-sized pharmaceutical company, near Nuremberg, Germany

• Documentation review
• Performance of gap assessment
• Back-office management

Audits and Inspections

Pharmaceuticals (biopharmaceuticals), parenterals

GMP, EU regulations, ISO guidelines (e.g., DIN EN ISO/IEC 17025)

Medium-sized subsidiary of global pharmaceutical company, Munich, Germany

• Internal inspections of quality assurance and release processes
• Audits of equipment suppliers or calibration services

FDA remediation

Pharmaceuticals (small molecules, oncology products), parenterals

GMP, US FDA regulations (21CFR 210 and 211)

Medium-sized subsidiary of a global pharmaceutical company, near Salzburg, Austria

• Deviation and CAPA management for the quality control department
• Deviations processing including investigation and root cause analysis for quality control and manufacturing
• Evaluation of OOS
• Troubleshooting in quality control and manufacturing
• Recall support
• Review of SOPs

Preparation of technical and marketing documentation

Sensors (in-line) for biotechnological production processes

Small sensor manufacturer, near Düsseldorf, Germany

• Evaluation of technical specifications
• Documentation preparation