a Randstad company

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

Profil
Top-Skills
Sachkundige Person AMG (QP) zur Chargenfreigabe, PQRs, GMP-Audits, RA:CMC-Projekte
Verfügbar ab
01.02.2023
Bald verfügbar - Für planbare Projekte: Der Experte steht für neue Folgeprojekte zur Verfügung.
Verfügbar zu
30%
davon vor Ort
100%
Einsatzorte

Städte
Frankfurt am Main (+100km)
PLZ-Gebiete
Länder
Deutschland
Remote-Arbeit
Nicht möglich
Art des Profiles
Freiberufler / Selbstständiger
Der Experte ist als Einzelperson freiberuflich oder selbstständig tätig.

10 Monate

2020-03

2020-12

Sachkundige Person AMG/ Leiter d. Herstellung AMWHV

QP / L.d.H.
Rolle
QP / L.d.H.
10 Monate

2019-03

2019-12

Prozessvalidierungen Downstreram im Biotech.-Bereich

QA-MAnager
Rolle
QA-MAnager
Einsatzort
Frankfurt/M.
3 Monate

2017-10

2017-12

Bewertung/ Trending analytischer Daten von Chargen für PQR/ APR

Trending Expert
Rolle
Trending Expert
8 Monate

2016-08

2017-03

Supporting Quality Assurance, Directorate GMP and Inspections

PQR Manager
Rolle
PQR Manager
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
Kunde
Merck KG a. A.
Einsatzort
Darmstadt
4 Monate

2016-02

2016-05

Supporting a QP Unit within Product Quality Assurance

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
Kunde
Boehringer Pharma GmbH & Co KG
Einsatzort
Ingelheim
11 Monate

2015-02

2015-12

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

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
Kunde
MEDA Pharma GmbH & Co KG
Einsatzort
Bad Homburg
7 Jahre 6 Monate

2007-06

2014-11

Qualified Person & Quality Control Manager

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
Kunde
GlaxoSmithKline Consumer HealthCare GmbH & Co KG (CHC)
1 Jahr 1 Monat

2013-07

2014-07

Supporting Quality Assurance units within project ? Inspection Readiness?

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)
Kunde
Boehringer Pharma GmbH & Co KG
Einsatzort
Ingelheim
4 Jahre 10 Monate

2009-09

2014-06

Qualified Person AMG/ EU & Quality Control Manager

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
Kunde
GlaxoSmithKline CHC Herrenberg Site, changed into OMEGA Pharma Manufact. GmbH & Co KG
3 Jahre 6 Monate

2008-06

2011-11

Head of Manufacture and Qualified Person for project Andante®

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
Kunde
Eisai GmbH
Einsatzort
Frankfurt/ Main
2 Jahre 7 Monate

2005-01

2007-07

Quality Manager AMG & Qualified Person AMG/ EU

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
Kunde
MEDA GmbH, Wiesbaden and MEDA Pharma GmbH & Co KG, Bad Homburg
11 Jahre

1994-01

2004-12

Free Lance Regulatory & Pharmaceutical Affairs Services

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
Kunde
Pharma Resources GmbH
Einsatzort
Ahrensburg, Basel, Dreieich
11 Jahre

1994-01

2004-12

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

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)
Kunde
Roth GmbH
Einsatzort
Karlsruhe-Germany
9 Jahre

1985-02

1994-01

Drug Registration Manager within the R&D Department

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
Kunde
STADA AG
Einsatzort
Bad Vilbel/ Germany
2 Jahre 4 Monate

1982-10

1985-01

Deputy Manager of Quality Control of a pharmaceutical company

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
Kunde
Krewel Werke Arzneimittel GmbH
Einsatzort
Eitorf/ Germany
4 Jahre

1978-10

1982-09

Head of a formulation lab of a pharmaceutical company

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

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

Top Skills
Sachkundige Person AMG (QP) zur Chargenfreigabe, PQRs, GMP-Audits, RA:CMC-Projekte
Produkte / Standards / Erfahrungen / Methoden
  • MS Office-Items (Word, Excel, etc.)
  • SAP-Systems (R3, GCOMS, IBIS)
  • Docum. Systems
  • Trackwise
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