a Randstad company

Interim-QP, Release and Importing, Regulatory Affairs, Quality Assurance.

Profil
Verfügbar ab
04.01.2023
Noch verfügbar - Schnell sein lohnt sich: Der Experte kann bereits für Projekte vorgesehen sein.
Verfügbar zu
100%
davon vor Ort
50%
Einsatzorte

Städte
Wien (+100km)
PLZ-Gebiete
Länder
Ganz Deutschland, Österreich
Remote-Arbeit
möglich
Art des Profiles
Mitarbeiter eines Dienstleisters
Der Experte ist ein festangestellter Mitarbeiter eines Unternehmens aus dem IT- und Engineering-Bereich.

7 Monate

2022-06

2022-12

Quality Technical Agreements

QTA/QAA Verhandlung
Rolle
QTA/QAA Verhandlung
Projektinhalte

Verhandlung von einem QTA -Backlog

Einsatzort
Stuttgart
3 Jahre 9 Monate

2017-09

2021-05

RA/QA/QC Executive

RA/QA/QC Executive
Rolle
RA/QA/QC Executive
Projektinhalte

Managed all ISO 9001, GMP and GDP licenses for the alliance and the clients from submission to recertification or withdrawal. Prepared registration documentation for clients. (clients from small Generic Companies with couple products to Global Pharma companies with more than 700 actives/ 8000 + MAs, registered globally including biosimilars or vaccines). Successfully obtained marketing authorizations for clients? products.

·      Preparation of registration documentation. Lifecycle management for medicinal products. Maintaining SmPC and PIL in line with EU-registered products.

·      Preparation and coordination of all SOPs. Management of GMP and GDP licenses of Pharmazet Alliance and its clients. Preparation for audit and inspections internal as well as external. Tracking all training schedules.

·      Sampling incoming imported medicinal products.


Einsatzort
Prag, Tschechien
1 Jahr 8 Monate

2016-01

2017-08

Production Support

Manufacturing Associate
Rolle
Manufacturing Associate
Projektinhalte

·      Manufacturing DCVAC in a clean lab (GMP)

·      Preparation of media for production in the clean lab

·      Administration of manufacturing protocols (GMP)

·      Distribution of DCVAC for application


Einsatzort
Tschechien

9 Monate

2017-10

2018-06

QP-Course

erfolgreich, Institute for Postgraduate Medical Education in Prague, Charles University
Abschluss
erfolgreich
Institution, Ort
Institute for Postgraduate Medical Education in Prague, Charles University
Schwerpunkt
QP-Course


2 Jahre 1 Monat

2013-01

2015-01

Chemie

MSc (Ing.), University of Chemistry and Technology Prague
Abschluss
MSc (Ing.)
Institution, Ort
University of Chemistry and Technology Prague
Schwerpunkt
Drug Production


3 Jahre 1 Monat

2010-01

2013-01

Chemie

BSC, University of Chemistry and Technology Prague
Abschluss
BSC
Institution, Ort
University of Chemistry and Technology Prague
Schwerpunkt
Drug Synthesis and Production


Consultant /Interim Quality/ Interim Management/ Pharma and Biotech

Ensures QMS support in all areas from writing to implementing SOPs, to training materials and the entire lifecycle management. QAA Negotiations, Change Control Management, Deviation investigation, and CAPA follow-ups. Interim Management of critical situations and guidance from a QP Perspective to support Clients? needs

· Eliminated causes of non-conformities and other undesirable situations through CAPA Management.

· Implementation of GxP requirements to ensure that pharmaceutical products are safe, meet their intended use and adhere to quality processes during manufacturing, control, storage, and distribution.

Czech Muttersprache
Deutsch Fortgeschritten
Englisch Verhandlungssicher

Marktzugang
Dossiervorbereitung
Experte
Dossierverwaltung
Experte
Qualitätssicherung
Qualitässicherungsvereinbarung
Experte
QAA
Experte
CAPA
Experte
Changemanagement
Experte
Abweichungsmanagemt
Experte

Pharma and Biotechology (LifeSciences)


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