QP für ATMP, Vaccine and Medicinal Products, Quality Assurance Expert, Clinical Quality Management
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- auf Anfrage
- 6020 Innsbruck
- Weltweit
- de | en | it
- 09.04.2021
Kurzvorstellung
Experienced quality assurance professional with PhD in Biological Science and Master in Business Administration (MBA) with a long standing history of working in the biotechnology/pharma industry. QP for ATMP, Vaccine and common Medicinal Products.
Qualifikationen
Projekt‐ & Berufserfahrung
Head Global Clinical Quality Assurance (Festanstellung)
Sandoz, Kundl
3/2009
–
8/2016
(7 Jahre, 6 Monate)
Tätigkeitszeitraum
3/2009 – 8/2016
Tätigkeitsbeschreibung
• Harmonize Clinical Quality Assurance procedures throughout Sandoz and affiliates
• Assure compliance to ethical and regulatory standards
• Provide interpretation on regulations, guidelines, policies and procedures
• Trend analysis of audit/inspection outcomes
• Deviation, CAPA and Change Control management
• Development and controlling of quantitative and qualitative KPI’s
• Management of strategic & operational projects
• Direct program for qualification/selection of third party providers
• Initiate and oversee global process improvement
Pharmaforschung
Zertifikate
Projektleiter und Beauftragte für Biologische Sicherheit
2020
GMP Grundlagen Sterilproduktion
2020
Qualified Person
2014
Ausbildung
Wirtschaft
MBA
2013
Wien
Wien
Molekular Biologie und Biochemie
2004
2004
Innsbruck
Innsbruck
Weitere Kenntnisse
♣ QP: ATMP; Biologics and Vaccines
♣ Extensive and broad knowledge of US and EU pharmaceutical regulations and guidelines (GCP, GLP, GMP)
♣ Creation and management of Clinical Development Plans; establishing timelines, budget and resource requirements
♣ Extensive experience in Third Party Management
♣ Establish and support clinical program strategy
♣ Experience in quality risk identification, mitigation and management
♣ Implementation of deviation, change control and CAPA processes
♣ Extensive and broad knowledge of US and EU pharmaceutical regulations and guidelines (GCP, GLP, GMP)
♣ Creation and management of Clinical Development Plans; establishing timelines, budget and resource requirements
♣ Extensive experience in Third Party Management
♣ Establish and support clinical program strategy
♣ Experience in quality risk identification, mitigation and management
♣ Implementation of deviation, change control and CAPA processes
Persönliche Daten
Sprache
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Italienisch (Grundkenntnisse)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
- Europäische Union
- Schweiz
- Vereinigte Staaten von Amerika
Profilaufrufe
2171
Alter
62
Berufserfahrung
24 Jahre und 7 Monate
(seit 09/1999)
Projektleitung
5 Jahre
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