
Name
Stefanie Schmidt
Function
Senior Consultant
Dr Stefanie Schmidt

Name
Stefanie Schmidt
Function
Senior Consultant
Dr Stefanie Schmidt

Name
Markus Färber
Function
Senior Consultant,
Qualified Person,
Lead Auditor
Dr Markus Färber
Senior Consultant; Qualified Person (German Pharmaceutical Legislation); Lead Auditor; Head of Quality Assurance; Deputy Head of Quality Control; Project Manager, Senior Manager QA Compliance; Laboratory Manager Quality Control; Head of Regulatory Affairs; professional and disciplinary management of employees; cGMP-Compliance; customer audits and Authority inspections; risk management; GMP-audits; qualification and validation; regulatory affairs; sterile manufacturing (on a contract basis; aseptic filling; terminal sterilization; lyophilization; visual inspection and secondary packaging); responsible for GMP - training; data integrity; cleaning validation; deviation- and CAPA - management; change control; self inspections, supplier–/service provider qualification; Product Quality Reviews; pest control; environmental monitoring; Quality Management reviews; validation master plan; annual reviews of GMP – relevant utility systems; development/transfer and validation of chemical-analytical test methods

Name
Jens Lipka
Function
Senior Consultant,
Qualified Person
Dr Jens Lipka
Experience so far
Qualified Person (German Pharmaceutical Legislation); Head of Quality Systems; Head of Quality Assurance; Deputy Head of Quality Control; Deputy Head of Manufacturing; Disciplinary Management of employees; GMP-Compliance; Customer Audits and Inspections of Health Authorities; Risk Management; GMP-Audits; Computer system validation; Data integrity; Implementation of eQMS; CAPA- and Deviation Management; Change Control; Processing and investigation of complaints; Batch-Record-Review; Training

Name
Denise Kranz
Function
GMP Support Officer
Dr Denise Kranz
M.Sc. in Biology, University of Basel,
CH-Basel
B.Sc. in Biology, University of Basel,
CH-Basel
Experience so far
Life Science Management (GxP, Quality Management, Regulatory Affairs), Project Management IPMA Level D, S4 laboratory, Persistence and Stability tests for risk group 4 viruses, Validation of disinfection and decontamination procedures for risk group 4 viruses, Virus production, TCID50 assay, Plaque assay, PCR/qPCR, Infection models (FELASA B), Cloning, Bacterial cultivation and diagnostics, ELISPOT assay, PBMCs, Production of monoclonal antibodies, Protein production and purification, Western blot

Name
Konrad Dreizler
Function
Senior Consultant,
Qualified Person
Dr Konrad Dreizler
Experience so far
Qualified person according to §15 german medicinal product act; Clinical studies (OL/DB); Investigational medicinal products; Solid dosage forms (tablets, capsules); Sterile dosage forms; Batch record review; Master batch record; Verification and approval of specifications; Deviations; Customer complaints; CAPAs; Preparation and review of work instructions, forms and checklists; Project leader for genetic engineering operations and installations (S1/S2); Biosafety Officer (S1/S2); Risk assessments for GMOs; Inspections by competent authorities (S1/S2); Self inspections; Audits; Trainings

Name
Monika Kaur Wagner
Function
Consultant,
Head of Quality Assurance/QMR
Monika Kaur Wagner
Experience so far
Department lead; Disciplinary Management of Employees; Project Management; Deputy Head of Manufacturing; Quality Assurance; Audits; Inspections; Training Management; Solid Dosage Forms; Process Validation; Cleaning Validation; Lean Six Sigma; OOx-, CAPA-, Complaint-, Deviation-Management; Change Control; PQR; Batch Record Review

Name
Sarah Baier
Function
Team Assistant,
IT Officer
Sarah Baier
Experience so far
IT Service Desk; Preparation and execution of software trainings; Event management; Marketing; Working in international project teams

Name
Helene Geese
Function
Senior Consultant,
Qualified Person
Dr Helene Geese
Experience so far
Head of Quality Assurance; disciplinary management of employees; audits; GMP compliance; OOx, CAPA and deviation management; change control; processing and investigation of complaints; cleaning validation; quality control; method transfer and validation; preparation of specifications; test instructions and protocols; Deputy Head of Production; batch record review; preparation of manufacturing and packaging instructions; process validation

Name
Elise Poschen
Function
Team Assistant,
Real Estate Manager
Elise Poschen
Experience so far
International sales and marketing assistance (B2B & B2C), customer service, trade fair organisation and participation, administration

Name
Benedikt Ball
Function
Senior Consultant,
Qualified Person
Dr Benedikt Ball
Experience so far
Qualified Person (German Pharmaceutical Legislation); Head of Manufacturing; Compounding products for patient individual parenteral nutrition solution; Responsible person for wholesale; Contract manufacturer of machine sterile filling; Lyophilization; Visual control and packaging; Responsible person for narcotic drugs (German Narcotic Drugs Act); Head of Quality Management for medical devices (ISO 13485) and terminal sterilized local anaesthetics; Head of Quality Control; Head of Regulatory Affairs; GMP-compliance; Batch-record-review; CAPA-and deviation management; Complaint management; Training; Risk management; Customer audits and inspections of health authorities; Product management

PharmaKorell GmbH
Georges-Köhler-Str. 2
79539 Lörrach
Germany
Tel. +49 7621 949860
info@pharmakorell.com

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