Name
Bastian Fleitz
Function
Senior Consultant,
Qualified Person
Bastian Fleitz
Experience so far
Monitoring of GMP Compliance incl. Incident Management; Preparation of Quality Management Reviews; Head QA and Deputy Head QC (Manufacturing of sterile liquid and lyophilized IMPs); Documentation of GMP Method Validation, Stability Studies and Analytical Procedures; Preparation of Product Quality Reviews; Safety Inspector; Deputy Head of Manufacturing
Name
Markus Scholz
Function
Senior Consultant
Dr Markus Scholz
Experience so far
Head of analytical development (development, validation, transfer of test methods, cleaning validation); Development of generics (small molecules); Head of quality control (solid and liquid dosage forms; analytical batch release); Head of Stability; Project management for internal and external customers; Customer support; Process optimization; Securing GMP compliance in laboratories; Compilation of registration documents (CTD, IMPD)
Name
Na Cheng
Function
Translator,
Interpreter,
Accountant
Na Cheng
Experience so far
Accounting; translation; Chinese lecturer
Name
Frank Wienen
Function
Managing Director,
Qualified Person,
Lead Auditor
Dr Frank Wienen
Experience so far
Qualified Person (German Pharmaceutical Legislation); Process Unit Head of Quality Management, Process Unit Head of Operations; Head of Production; Deputy Head of Production; responsible person for narcotic drugs (German Narcotic Drugs Act); Project Management -Site FDA Compliance project; Head of Quality Control; responsible for safety, GMP compliance, training status, training, improvement processes; Manufacturing and packaging solid, semi-solid dosage forms; Packaging of sterile dosage forms, clinical samples (IMP); Lead GMP Auditor; analytical method transfers, implementation of cleaning validation, sterilization processes; Stability studies;
Name
Asta Handke
Function
Warehouse and Shipping,
Team Assistant,
Administration
Asta Handke
Experience so far
System Manager HP3000; Administration in SAP/R3 Environment; SAP Basis in Batch Jobs and User Authorizations; Maintenance support in GMP Environment; Purchase and Administration of spare parts; Order Processing
Name
Piraieh Yamini
Function
Senior Consultant,
Qualified Person
Piraieh Yamini
Experience so far
Qualified Person (German Pharmaceutical Legislation); Deputy Head of Manufacturing; Implementation of a Corporate Quality Management System according to EU GMP and EU GDP; Establishment of Centralized Quality Agreements; Head of Corporate QA; GDP Responsible Person; Team Leader; Responsible Person for Narcotics; Experiences in Project Management; Process Management; Implementation of a Quality Management System in a pharmacy
Name
Susanne Zwicky-Beisele
Function
Senior Consultant,
Lead Auditor
Susanne Zwicky-Beisele
Experience so far
Project Lead; Project management pharmaceutical development/analytical development (focus Quality Control of solid dosage forms), Head of Analytics; Head of laboratory method development; validation; transfer and cleaning validations; Responsible Compliance laboratory equipment and laboratory software (focus qualification, risk analysis, investments); GMP training; Team Lead; Deputy Head of Quality Control
Name
Cora Büttner
Function
Senior Consultant,
Qualified Person
Dr Cora Büttner
Experience so far
Qualified Person (German Pharmaceutical Legislation) commercial and Investigational Medicinal Products; Product development of inhalation products (focus quality control); Establishment and continuous improvement of a quality system (focus quality control and release); Trainings; Risk management; Lean Six Sigma; Head of Quality Control; Deputy Head of (GLP)-Test Facility; Team lead; Project lead
Name
Wiebke Hallensleben-Steen
Function
Senior Consultant,
Qualified Person,
Lead Auditor
Dr Wiebke Hallensleben-Steen
Experience so far
Senior Consultant; Lead-Auditor; Deputy Head of Quality Control; Deputy Head of Manufacturing; Quality Management ISO 9001 and ISO 13485; Quality Assurance Manager GMP/GDP; Deputy Head of Quality Assurance; Document management; CAPA- and deviation management; Supplier qualification; GMP/GDP training; Quality agreements; Product quality reviews; Project management; Head of Quality Control department; Development of gene expression analysis methods on microarrays
Name
Christiane Maise
Function
Team Assistant,
Web Content Manager
Christiane Maise
Experience so far
Marketing assistance; Web Content Management; Executive secretary
PharmaKorell GmbH
Georges-Köhler-Str. 2
79539 Lörrach
Germany
Tel. +49 7621 949860
info@pharmakorell.com
We support the work of Pharmacists Without Borders Germany e.V.
We support the foundation outpatient children hospice Munich.
PharmaKorell GmbH
Schleißheimer Str. 373
80935 München
Germany
Tel. +49 89 24883410
info@pharmakorell.com
PharmaKorell GmbH
Lörracherstrasse 60
4125 Riehen/Basel
Switzerland
Tel. +41 79 1396748
info@pharmakorell.com