Fachlicher Schwerpunkt dieses Freiberuflers

Pharma Qualitätssicherung incl Validierungen, Sachkundige Person AMG (QP), GMP-Audits, PQRs, CMC-RA -Projekte,

verfügbar ab
15.07.2020
verfügbar zu
40 %
davon vor Ort
100 %
PLZ-Gebiet, Land

D3

D5

D6

D7

Städte
Frankfurt am Main
100 km
Kontaktwunsch

Ich möchte ausschließlich für Projekte in diesen Einsatzorten kontaktiert werden.

Projekte

03/2020 - 12/2020

10 Monate

Sachkundige Person AMG/ Leiter d. Herstellung AMWHV

Rolle
QP / L.d.H.

03/2019 - 12/2019

10 Monate

Prozessvalidierungen Downstreram im Biotech.-Bereich

Rolle
QA-MAnager
Einsatzort
Frankfurt/M.

10/2017 - 12/2017

3 Monate

Bewertung/ Trending analytischer Daten von Chargen für PQR/ APR

Rolle
Trending Expert

08/2016 - 03/2017

8 Monate

Supporting Quality Assurance, Directorate GMP and Inspections

Rolle
PQR Manager
Kunde
Merck KG a. A.
Einsatzort
Darmstadt
Projektinhalte
  • Filing and establishing of PQRs/ APRs,  Particular chapters: assessment of analytical test results of batches with evaluation of trending charts (process verification), stability tests, deviation management and CAPA, final conclusion

02/2016 - 05/2016

4 Monate

Supporting a QP Unit within Product Quality Assurance

Kunde
Boehringer Pharma GmbH & Co KG
Einsatzort
Ingelheim
Projektinhalte
  • Filing and establishing of PQRs/ APRs,
  • Particular chapters: compilation of analytical test results of manufactured batches with detailed assessment of trending charts (process verification), stability tests and complaints, deviation management and CAPA, final conclusion

02/2015 - 12/2015

11 Monate

Reg. Affairs Manager for national and international procedures (MRP/ DCP)

Kunde
MEDA Pharma GmbH & Co KG
Einsatzort
Bad Homburg
Projektinhalte
  • Maintenance and renewals of marketing authorisations, variations (Labelling, SmPC and technical-analytical changes within CMC documents )
  • MAH transfers world-wide subsequent to an acquisition project

06/2007 - 11/2014

7 Jahre 6 Monate

Qualified Person & Quality Control Manager

Kunde
GlaxoSmithKline Consumer HealthCare GmbH & Co KG (CHC)
Projektinhalte
  • Batch record review and final release of commercial batches for marketing (SAP-System), mainly liquids and solid forms, moreover semi-solid forms
  • Training of staff for sampling and quality control
  • Up-dates of QOS for pharmaceut. dossiers (Module 2) for renewals and variations
  • Establishing, approval and up-dating of pharmaceutical-technical agreements with pharmaceutical contractors and suppliers
  • Maintenance of local quality assurance system with system of documents (SOPs and Working Procedures)
  • Audits of contract manufacturers and suppliers (DE and CH)
  • Processing, approval and co-signing of PQRs
  • Arrangements for stability tests of solid pharmaceutical forms with process validation experiments

07/2013 - 07/2014

1 Jahr 1 Monat

Supporting Quality Assurance units within project “ Inspection Readiness”

Kunde
Boehringer Pharma GmbH & Co KG
Einsatzort
Ingelheim
Projektinhalte
  • Drug substances, - Finished products
  • Review of deviations and quality related complaints
  • Root cause analysis, Final review and possible assignment of CAPA
  • Documentation by PC (MS Word, MS Excel, SAP)

09/2009 - 06/2014

4 Jahre 10 Monate

Qualified Person AMG/ EU & Quality Control Manager

Kunde
GlaxoSmithKline CHC Herrenberg Site, changed into OMEGA Pharma Manufact. GmbH & Co KG
Projektinhalte
  • Batch record review and final release of commercial batches for marketing (SAP-System), mainly liquids and solid forms, moreover semi-solid forms
  • Training of staff for sampling and quality control
  • Up-dates of QOS for pharmaceut. dossiers (Module 2) for renewals and variations
  • Establishing, approval and up-dating of pharmaceutical-technical agreements with pharmaceutical contractors and suppliers
  • Maintenance of local quality assurance system with system of documents (SOPs and Working Procedures)
  • Audits of contract manufacturers and suppliers (DE and CH)
  • Processing, approval and co-signing of PQRs
  • Arrangements for stability tests of solid pharmaceutical forms with process validation experiments

06/2008 - 11/2011

3 Jahre 6 Monate

Head of Manufacture and Qualified Person for project Andante®

Kunde
Eisai GmbH
Einsatzort
Frankfurt/ Main
Projektinhalte
  • Arrangements for the import of bulk drug product from Japan (MRA-country) and quality control of bulk product in Germany
  • Release of finished product after packaging and final product release for marketing
  • Provisions and establishing a quality assurance system in Germany for the import, manufacturing & quality control of Andante®
  • Technical agreements with supplier and evaluation of warehouse & distribution centre, - Filing/ establishing of PQR

01/2005 - 07/2007

2 Jahre 7 Monate

Quality Manager AMG & Qualified Person AMG/ EU

Kunde
MEDA GmbH, Wiesbaden and MEDA Pharma GmbH & Co KG, Bad Homburg
Projektinhalte
  • Arrangements for stability tests with for antibiotic formulations
  • Up-dates of pharmaceutical dossiers (Module 2, 3 ) and Quality-Declarations for renewals and variations
  • Establishing, approval and up-dating of pharmaceutical-technical agreements with pharmaceutical contractors
  • Audits of contract manufacturers with follow-up actions (DE, CH, GR, IT)
  • Batch record review and final release of commercial batches for marketing (SAP-System), mainly solid forms, moreover parenteral forms (i.e. Hyaluronic acid, Thioctic acid)
  • Reception of quality related complaints and final response to patients and pharmacists, -Initiation and assignments of CAPA

01/1994 - 12/2004

11 Jahre

Free Lance Regulatory & Pharmaceutical Affairs Services

Kunde
Pharma Resources GmbH
Einsatzort
Ahrensburg, Basel, Dreieich
Projektinhalte
  • European Drug Master Files (EDMFs) for active pharmaceutical ingredients and filing of pharmaceutical documentations incl. Expert Report/ Quality Overall
    Summary (QOS)
  • Mutual Recognition Procedures (CTD format) performed with several European Health Authorities
  • Development of a class III medical device accdg. to EC Guideline 93/42, i.e. pre-filled sterile syringe for intra-articular injections (Hyaluronic acid, sodium) incl. risk analysis and arrangements with contractors and suppliers

01/1994 - 12/2004

11 Jahre

Assistant Manager and Member of the Managing Board of a fine chemical company

Kunde
Roth GmbH
Einsatzort
Karlsruhe-Germany
Projektinhalte
  • Responsible Person for Manufacture/ Quality Control
    according to German Drug Law
  • Establishing a range of analytical reference standards for pharmaceutical analytical laboratories.
  • Review of Pharmaceutical Products and Renewals (Nachzulassung)

02/1985 - 01/1994

9 Jahre

Drug Registration Manager within the R&D Department

Kunde
STADA AG
Einsatzort
Bad Vilbel/ Germany
Projektinhalte
  • Responsible for the management of national and international applications for the approval of medicinal products
  • Multi State Procedures for Generics, national procedures for OTC-Products
  • Transdermal Systems: Duragesic

10/1982 - 01/1985

2 Jahre 4 Monate

Deputy Manager of Quality Control of a pharmaceutical company

Kunde
Krewel Werke Arzneimittel GmbH
Einsatzort
Eitorf/ Germany
Projektinhalte
  • Responsible for tasks of QC lab (part time) and pharmaceutical development (parttime, mainly developing tablets)
  • Processing and development of chemical-pharmaceutical dossiers
  • Co-operation with Syntex Pharmaceuticals within Project Naproxen-Sodium

10/1978 - 09/1982

4 Jahre

Head of a formulation lab of a pharmaceutical company

Einsatzort
Klosterfrau/ Köln
Projektinhalte
  • Development of OTC-Products (e.g. Spray-dry technology, encapsulation of essential oils)
  • Formulation of med. devices for urological use (Farco Pharma GmbH)

Kompetenzen

Produkte / Standards / Erfahrungen
  • MS Office-Items (Word, Excel, etc.)
  • SAP-Systems (R3, GCOMS, IBIS)
  • Docum. Systems
  • Trackwise

Ausbildungshistorie

02/1978

Warded Doctor title (Organic Chemistry, Biochemistry, Pharmaceutical Biology)

1976 -1979

Undergraduate studies in Pharmacy (1. Staatsexamen)

1975 -1978

Postgraduation and dissertation in Organic Chemistry

1970 - 1975

Undergraduate studies in Chemistry at Philipps-University/ Marburg