Creation of documents for Post Approval Supplements
Creation of Comparability Protocols/ PACMP documents
Review of regulatory documentation
Support in compiling information for submission, answering agency questions and deficiency letters
Pharmaceutical company (FDA)
Process Validation ? Transfer projects and Life Cycle Management
Creation of transfer documentation
Risk analysis and management
Process Validation and Continued Process Verification
Pharmaceutical company (FDA)
Transfer Projects
Conduction of Gap Assessments
Development of technology transfer strategies
Creation of transfer documentation
Process Risk Management (FMEA)
Process optimization and deviation handling
Creation of validation documentation
Review of GMP documentation (eg. Master Batch Records, SOPs, L&E-study reports, stability study reports, cleaning validation documentation, filter validation studies)
Pharmaceutical company ? Biotech (API)
Transfer Project
Risk Management (Process FMEA)
Training (e.g. Risk Management, Process Validation, statistical basics)
Creation of transfer documentation
Conducting of comparability studies
Development of Control Strategies for buffer and process solutions
Deviation handling, trouble shooting
Change Management
Creation of SOPs
Review of CMO documents (e.g. Master Batch Records, Process Validation documentation, Risk Management, SOPs, Cleaning Validation concepts)
Pharma ? API ? Biotech
12 Jahre 7 Monate
2009-10 - 2022-04
various projects
Senior Consultant
Senior Consultant
Projects
API manufacturer Implementation of a QA-system up to the acquirement of the GMP-certificate Pharmaceutical company
GMP-upgrade, main topics
Process optimization
Creation of batch manufacturing records
Process validation of liquid, semisolid and solid dosage forms as well as sterile products
Deviation handling
Change Management
Improvement of QA-systems
Training of manufacturing staff (manufacturing technologies, hygiene and GMP basics)
Preparation of inspections/ participation in inspections
Pharmaceutical company
GMP-upgrade project, main topics
Human resource planning
Implementation of GMP- conform documentation
Preparation of inspections
Training of manufacturing staff
Pharmaceutical company (FDA)
GMP-upgrade project, main topics
Process optimization and transfer
Development of transfer strategy
Creation of transfer documentation
Risk analysis and management
Process Validation of aseptic products
Pharmaceutical company Implementation of the process of drug product serialisation Pharmaceutical company - Biotech
Transfer Project
Compilation of knowledge package and knowledge transfer
Preparation of Transfer Documentation
Risk Management
Process Validation
Change Management and Deviation Handling
Trouble Shooting
Support in compiling information for submission and answering agency questions and deficiency letters
Seminars and in-house trainings GMP in manufacturing/ packaging, Hygiene, GMP conform documentation, Product Quality Review, Process Validation, Ongoing Process Verification
gmp-experts GmbH/ Experts Institut GmbH
2 Jahre 7 Monate
2006-04 - 2008-10
Production
Head of manufacturing
Head of manufacturing
CMO for manufacturing and packaging of solid dosage forms
Klocke Pharma Service GmbH
1 Jahr 9 Monate
2004-07 - 2006-03
various projects
Assistant to the head of manufacturing
Assistant to the head of manufacturing
Projects
Implementation of Cleaning Validation concept
Qualification projects and Process Validation
GMP conform renovation of the manufacturing areas
Integration of diverse new equipment and facilities
Klocke Pharma Service GmbH
Aus- und Weiterbildung
Aus- und Weiterbildung
1 Monat
2004-05 - 2004-05
Pharmacist
Johannes-Gutenberg-University, Mainz (Germany)
Johannes-Gutenberg-University, Mainz (Germany)
Einsatzorte
Einsatzorte
Deutschland, Schweiz, Österreich
möglich
Projekte
Projekte
3 Jahre 10 Monate
2022-05 - heute
various projects
Freelance Consultant
Freelance Consultant
Projects
Pharmaceutical company (FDA)
Regulatory support
Creation of documents for Post Approval Supplements
Creation of Comparability Protocols/ PACMP documents
Review of regulatory documentation
Support in compiling information for submission, answering agency questions and deficiency letters
Pharmaceutical company (FDA)
Process Validation ? Transfer projects and Life Cycle Management
Creation of transfer documentation
Risk analysis and management
Process Validation and Continued Process Verification
Pharmaceutical company (FDA)
Transfer Projects
Conduction of Gap Assessments
Development of technology transfer strategies
Creation of transfer documentation
Process Risk Management (FMEA)
Process optimization and deviation handling
Creation of validation documentation
Review of GMP documentation (eg. Master Batch Records, SOPs, L&E-study reports, stability study reports, cleaning validation documentation, filter validation studies)
Pharmaceutical company ? Biotech (API)
Transfer Project
Risk Management (Process FMEA)
Training (e.g. Risk Management, Process Validation, statistical basics)
Creation of transfer documentation
Conducting of comparability studies
Development of Control Strategies for buffer and process solutions
Deviation handling, trouble shooting
Change Management
Creation of SOPs
Review of CMO documents (e.g. Master Batch Records, Process Validation documentation, Risk Management, SOPs, Cleaning Validation concepts)
Pharma ? API ? Biotech
12 Jahre 7 Monate
2009-10 - 2022-04
various projects
Senior Consultant
Senior Consultant
Projects
API manufacturer Implementation of a QA-system up to the acquirement of the GMP-certificate Pharmaceutical company
GMP-upgrade, main topics
Process optimization
Creation of batch manufacturing records
Process validation of liquid, semisolid and solid dosage forms as well as sterile products
Deviation handling
Change Management
Improvement of QA-systems
Training of manufacturing staff (manufacturing technologies, hygiene and GMP basics)
Preparation of inspections/ participation in inspections
Pharmaceutical company
GMP-upgrade project, main topics
Human resource planning
Implementation of GMP- conform documentation
Preparation of inspections
Training of manufacturing staff
Pharmaceutical company (FDA)
GMP-upgrade project, main topics
Process optimization and transfer
Development of transfer strategy
Creation of transfer documentation
Risk analysis and management
Process Validation of aseptic products
Pharmaceutical company Implementation of the process of drug product serialisation Pharmaceutical company - Biotech
Transfer Project
Compilation of knowledge package and knowledge transfer
Preparation of Transfer Documentation
Risk Management
Process Validation
Change Management and Deviation Handling
Trouble Shooting
Support in compiling information for submission and answering agency questions and deficiency letters
Seminars and in-house trainings GMP in manufacturing/ packaging, Hygiene, GMP conform documentation, Product Quality Review, Process Validation, Ongoing Process Verification
gmp-experts GmbH/ Experts Institut GmbH
2 Jahre 7 Monate
2006-04 - 2008-10
Production
Head of manufacturing
Head of manufacturing
CMO for manufacturing and packaging of solid dosage forms
Klocke Pharma Service GmbH
1 Jahr 9 Monate
2004-07 - 2006-03
various projects
Assistant to the head of manufacturing
Assistant to the head of manufacturing
Projects
Implementation of Cleaning Validation concept
Qualification projects and Process Validation
GMP conform renovation of the manufacturing areas
Integration of diverse new equipment and facilities
Klocke Pharma Service GmbH
Aus- und Weiterbildung
Aus- und Weiterbildung
1 Monat
2004-05 - 2004-05
Pharmacist
Johannes-Gutenberg-University, Mainz (Germany)
Johannes-Gutenberg-University, Mainz (Germany)
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Im Bereich Freelancing
Im Bereich Arbeitnehmerüberlassung / Personalvermittlung