Audit Experts
Mrs. Wang
1983 ~ 1988：Wuxi Institute of Medicine, Laboratory Engineer 1988 ~ 1994：The Huarui Pharmaceutical Co., Ltd., the production Supervisor 1994 ~ 1996：Astra Pharmaceutical Co., Ltd., Logistics Manager 1996 ~ 2001：Astra Pharmaceutical Co., Ltd., Logistics Manager 2001 ~ 2008：Astra-Zeneca Pharmaceutical Co., Ltd., Logistics &Purchasing Manager Since 2008：TSI (China) Co., Ltd., Supply Chain Manager Since 2013: Phexcom Auditor
1983 ~ 1988：Wuxi Institute of Medicine, Laboratory Engineer 1988 ~ 1994：The Huarui Pharmaceutical Co., Ltd., the production Supervisor 1994 ~ 1996：Astra Pharmaceutical Co., Ltd., Logistics Manager 1996 ~ 2001：Astra Pharmaceutical Co., Ltd., Logistics Manager 2001 ~ 2008：Astra-Zeneca Pharmaceutical Co., Ltd., Logistics &Purchasing Manager Since 2008：TSI (China) Co., Ltd., Supply Chain Manager Since 2013: Phexcom Auditor
Dr. Joachim Erler
For more than 25 years experience in the Pharmaceutical Industry as Head of QC, Head of Manufacturing and Qualified Person. Since 04/2010 management consultant in the pharmaceutical industry Accomplished several GMP licenses for non EU companies; External QP for pharmaceutical companies / API manufacturer; GMP / ISO audits worldwide (EU GMP II, I, GACP, ISO 9001); more than 120 audits since 4/2010. Since 2014 PHEXCOM Audit Consultant
For more than 25 years experience in the Pharmaceutical Industry as Head of QC, Head of Manufacturing and Qualified Person. Since 04/2010 management consultant in the pharmaceutical industry Accomplished several GMP licenses for non EU companies; External QP for pharmaceutical companies / API manufacturer; GMP / ISO audits worldwide (EU GMP II, I, GACP, ISO 9001); more than 120 audits since 4/2010. Since 2014 PHEXCOM Audit Consultant
Mag. rer. nat. Martin Nemecz
Many years of experience in the pharmaceutical industry as consultant and regulatory affairs expert. Qualified Person. Coordination of regulatory affairs, Research and development of drugs, especially generic products. Audits in Europe and Asia. Since 04/2008 Maximilian Pharma e.U., Regestered Proprietor § Regulatory services, Pharmacovigilance § Coordination of applications for marketing authorisations for pharmaceutical products § Management of inspections by European authorities for non-European manufacturing sites. (Finished dosage forms and APIs) § Business development for Austrian, Germany and eastern Europe Since 2015 PHEXCOM Audit Consultant
Many years of experience in the pharmaceutical industry as consultant and regulatory affairs expert. Qualified Person. Coordination of regulatory affairs, Research and development of drugs, especially generic products. Audits in Europe and Asia. Since 04/2008 Maximilian Pharma e.U., Regestered Proprietor § Regulatory services, Pharmacovigilance § Coordination of applications for marketing authorisations for pharmaceutical products § Management of inspections by European authorities for non-European manufacturing sites. (Finished dosage forms and APIs) § Business development for Austrian, Germany and eastern Europe Since 2015 PHEXCOM Audit Consultant
Claudia A. Birhala
Many years of experience in the pharmaceutical industry as Production and Quality Manager. Lead auditor audits for third parties, more than 40 audits performed to APIs, packaging materials, contract manufacturing in China, India and Europe. Since 2009 SANOFI GENERICS- Pharma Solids Zentiva SA, Romania ,Quality Manager § Building the EU control and release centre for products manufactured outside Europe; § Implementation of LIMS system in QC Lab; § Build a quality system for Authorization of investigational medicinal products for solids and pellets with success clinical studies; Since 2015 PHEXCOM Audit Consultant
Many years of experience in the pharmaceutical industry as Production and Quality Manager. Lead auditor audits for third parties, more than 40 audits performed to APIs, packaging materials, contract manufacturing in China, India and Europe. Since 2009 SANOFI GENERICS- Pharma Solids Zentiva SA, Romania ,Quality Manager § Building the EU control and release centre for products manufactured outside Europe; § Implementation of LIMS system in QC Lab; § Build a quality system for Authorization of investigational medicinal products for solids and pellets with success clinical studies; Since 2015 PHEXCOM Audit Consultant