Project Overview

FDA Remediation

Sterile filling of small molecules and biopharmaceutical products

GMP, EU and US regulations, national requirements

German subsidiary of an US pharmaceutical company, near Bielefeld, Germany

• Deviation-, CAPA- and Change-Management
• Review of SOPs
• Batch Record Review

Interim Manager Quality Assurance

Sterile filling of biopharmaceutical products

GMP, EU and US regulations, national requirements

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

• Deviation-, CAPA- and Change-Management
• Review and approval of SOPs
• Quality Manager for API department, infrastructure and hygiene

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 US, 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

FDA inspection, preparation, support, and follow-up

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

GMP, EU and US regulations, national requirement

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 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 regulations

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 regulations

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 regulations

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 regulations

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