Not subcontracted, not on call. The statutory roles under the AMG are held personally by our own staff, and everyone works at our own sites in Efringen-Kirchen and Itzehoe. You can contact each of them directly.
Dr. Olaf Mundszinger
Founder and Managing Director
QP
Dr. Olaf Mundszinger runs A&O Pharma and is a Qualified Person (QP) under § 14 AMG. He studied pharmaceutical sciences and chemistry and holds a doctorate in analyti...
Education
Doctorate in analytical chemistry, degree in pharmaceutical sciences and chemistry
Key areas
- Pharmaceutical quality control and quality assurance
- Narcotics Officer
- IMPD preparation
- Pharmaceutical analysis
Dr. Klaus-Peter Kreth
Qualified Person (QP) under § 14 AMG
QP
Dr. Klaus-Peter Kreth is a Qualified Person (QP) under § 14 AMG and is qualified to act as Head of Quality Control and Head of Production under the AMWHV. He is a li...
Education
Licence to practise as a pharmacist, doctorate in pharmaceutical analysis, specialist pharmacist in pharmaceutical analysis
Key areas
- Quality management
- Operational QA
- Inspection preparation, support and follow-up
- Auditor
Ute Hegener
Regulatory Affairs
Ute Hegener works in regulatory affairs and has more than twenty years of experience in marketing authorisations. She studied biology with a focus on molecular biolo...
Education
Degree in biology with a focus on molecular biology, plant metabolic physiology and enzyme chemistry, over 20 years of experience
Key areas
- Marketing authorisation
- Strategic consulting
- EU authorisation procedures
- Lifecycle maintenance
Dr. Barbara Siebertz
Regulatory Affairs
Dr. Barbara Siebertz works in regulatory affairs and has more than fifteen years of experience. She studied biology with a focus on molecular biology, biochemistry a...
Education
Degree in biology with a doctorate, focus on molecular biology, biochemistry and botany, over 15 years of experience
Key areas
- Lifecycle maintenance
- Regulatory affairs
- Quality management
Alexander Trautmann
GMP Consulting and Training
Alexander Trautmann is a licensed pharmacist and is responsible for GMP consulting and training at A&O Pharma. He works in strategic GxP consulting, operational QM s...
Education
Licence to practise as a pharmacist
Key areas
- GMP consulting
- GMP training
- ISO 13485, MDR and IVDR
- Regulatory inspections
Leidy Fajardo
Risk Assessment and GMP Documentation
Leidy Fajardo is responsible for risk assessment and GMP documentation. She holds a bachelor's degree in pharmaceutical chemistry, a master's degree in biomedical in...
Education
B.Sc. Pharmaceutical Chemistry, M.Sc. Biomedical Informatics, specialisation in strategic corporate management
Key areas
- Risk assessment
- GMP documentation
- Data science
Dr. Kai Huwig
Qualified Person (QP) and Head of Quality Control
QP
Dr. Kai Huwig is a Qualified Person (QP) under § 14 AMG and Head of Quality Control. He studied chemistry, holds a doctorate in the subject and acquired the expert k...
Education
Degree and doctorate in chemistry, postgraduate pharmacy programme to acquire the expert knowledge required under § 15 AMG
Key areas
- Qualified Person under § 14 AMG
- Validation of analytical methods
- Head of Quality Control under the AMWHV
Dr. Emmanuel Bey
Analytical Development
QP
Dr. Emmanuel Bey is responsible for analytical development and is a Qualified Person (QP) under § 14 AMG. He holds a doctorate in pharmaceutical chemistry. At A&O Ph...
Education
Doctorate in pharmaceutical chemistry
Key areas
- Analytical development, including validation and transfer of analytical methods
- IMPD and dossier preparation
Tatjana Pazer
Quality Management and Sterile Manufacturing
QP
Tatjana Pazer is responsible for quality management and sterile manufacturing and is a Qualified Person (QP) under § 14 AMG. She studied pharmacy, is a licensed phar...
Education
Degree in pharmacy, licence to practise as a pharmacist, pharmaceutical technical assistant
Key areas
- Sterile manufacturing and compounding
- Computer system validation
- Lean, efficient quality management
- Auditor
Dr. Lenka Taylor
Investigational Medicinal Products and GCP
QP
Dr. Lenka Taylor is responsible for investigational medicinal products and GCP and is a Qualified Person (QP) under § 14 AMG. She holds a doctorate in clinical analy...
Education
Doctorate in clinical analysis, specialist pharmacist in clinical pharmacy
Key areas
- GCP and GMP consulting
- GCP training
- Clinical trial planning
- IMPD preparation
Sascha Manthei
Business Development
QP
Sascha Manthei is responsible for business development at A&O Pharma and is a pharmacist and Qualified Person (QP) under § 14 AMG. He is responsible for pharmaceutic...
Education
Banking apprenticeship, degree in pharmacy, licence to practise as a pharmacist, Master of Business Administration (MBA)
Key areas
- Qualified Person under § 14 AMG
- Pharmaceutical quality management
- GMP consulting
- Auditor
Dr. Thomas Lutz
Qualified Person (QP) and Head of Production
QP
Dr. Thomas Lutz is a Qualified Person (QP) under § 14 AMG and Head of Production under the AMWHV. A pharmacist with a doctorate in pharmaceutical chemistry, he is al...
Education
Degree in pharmacy, licence to practise as a pharmacist, doctorate in pharmaceutical chemistry
Key areas
- Qualified Person under § 14 AMG
- Head of Production under the AMWHV
- Responsible person for wholesale distribution of medicinal products under § 52a AMG
- Stufenplanbeauftragter under § 19(7) AMWHV
Dr. Anne Katharina Schmidt
Head of Quality Control
Dr. Anne Katharina Schmidt is Head of Quality Control at the Itzehoe site and holds a doctorate in supramolecular chemistry. In this role, she is responsible for man...
Education
Degree in chemistry followed by a doctorate in supramolecular chemistry.
Key areas
- Quality control
- Pharmaceutical analysis
- Validation, verification and transfer of methods
- Evaluation and release of analytical results
Florian Göttsche
Laboratory Manager and Head of Instrumentation
Florian Göttsche is Laboratory Manager and Head of Instrumentation at the Itzehoe site. As a trained dairy laboratory technician and certified pharmaceutical sales r...
Education
Trained dairy laboratory technician, certified pharmaceutical sales representative
Key areas
- Instrument maintenance and qualification
- Evaluation and release of analytical results
- Planning and coordination of routine testing
- Validation of analytical methods
Michel Tornow
Laboratory Project Manager
Michel Tornow is a laboratory project manager at the Itzehoe site and is responsible for implementing and developing analytical methods. As a trained chemical labora...
Education
Trained chemical laboratory technician
Key areas
- Project planning and coordination
- Validation, verification and transfer of methods
- Development of analytical methods
- Validation of Excel spreadsheets
