15 beste Stellen als process engineering in graz st – aktuell auf Personalsuche

Director Quality Operations Development Programs & LCM (m/f/d)
Fresenius Kabi Austria GmbH —Graz, ST
- Vollzeit
- Doktorat
- Master
- Bachelor
11 Tage
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Kardex Austria GmbH —Graz, ST
- Bachelor
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- Bachelor
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PENTANOVA GmbH —Gleisdorf, ST
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Research Center Pharmaceutical Engineering GmbH —Graz, ST
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PENTANOVA GmbH —Gleisdorf, ST
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NXP Semiconductors —Gratkorn, ST
- Vollzeit
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Senior System Security Architect (m/f/d)
NXP Semiconductors —Gratkorn, ST
- Vollzeit
- Doktorat
- Master
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PENTANOVA GmbH —Gleisdorf, ST
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NXP Semiconductors —Gratkorn, ST
- Vollzeit
- Doktorat
- Master
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ams-OSRAM AG —Unterpremstätten, ST
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Deine Lehrstelle bei MAGNA Presstec in Weiz!
Magna International —Weiz, ST
Direkt bewerben
Supplier Quality Engineer Intern
ZF Foxconn Chassis Modules GmbH —Grambach, ST
- Vollzeit
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Project Buyer (m/f/d)
Kardex Austria GmbH —Graz, ST
Prepare requests for quotations (RFQs) for project materials and review, validate, and implement resulting orders in the ERP system.
Direkt bewerben
4 Tage

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process engineering jobs near graz st

Director Quality Operations Development Programs & LCM (m/f/d)

Fresenius Kabi Austria GmbH -
Graz, ST

Jetzt bewerben

Details zur Stelle

Vollzeit
vor 11 Tagen

Qualifikationen

Doktorat
Master
Bachelor

Vollständige Stellenbeschreibung

Your tasks

Maintain an up-to-date knowledge of cGxP regulation and applicable standards (especially in the US and EU) and implement requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc)
Manage a GMP compliant transition of Programs from development to commercial
Manage GMP compliance during Tech Transfer of manufacturing activities of Drug Substance, Drug Product and/or Combination Product by authoring, reviewing, approving, as applicable, protocols, plans and reports (e.g. Validations) and identify the risks and establish appropriate mitigation plan
Manage GMP compliance during Analytical Transfer activities
Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to Drug Substance, Drug Product and Combination Products
Contribute to QM programs and GMP/GDP/MDR compliance activities as appropriate
Act on behalf of Senior Director Quality Operations with regards to subjects related to Quality Operations and Quality Life-Cycle Management

Our expectations

A BA/BS, MA/MS or PhD in a technical or engineering discipline or related field
Minimum 10 years’ experience in a Quality function with increasing levels of responsibility in the biotech, lifescience or pharmaceutical industry
Strong understanding and interpretation of Quality Standards (such as ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10), cGMP requirements for Pharmaceuticals and Combination Products, including Biologic Products
Strong understanding of GMPs and best quality practices with regards to biotech manufacturing processes
Experience with regulatory agencies such as the FDA, EMA, etc
Proven success in third-parties’ quality management
Excellent communication skills in English, both written and oral
Demonstrated skills in Leadership, Drive, Intensity, Enthusiasm

We offer

Highly varied range of tasks
Training opportunities and personal development within the company
Career opportunities in an international pharmaceutical company
Attractive, performance-based remuneration (minimum gross annual salary of € 75,000; higher salary depending on qualifications)

We are caring for our employees

Reliable employer
Strong global growth
International career opportunities
Comprehensive education and training
Homeoffice
Jobticket
Active health promotion
Free parking space
Bikeleasing
Canteen
Joint company events

Fresenius Kabi Austria
Mag. Celina Gößler, MA
Hafnerstraße 36
8055 Graz

Jetzt bewerben

Erweiterte Suche

process engineering Jobs in graz st

Director Quality Operations Development Programs & LCM (m/f/d)

Project Buyer (m/f/d)

After sales Service Manager

Automation Technician (m/f/d)

Internship: UWB Validation Test Management Automotive UWB (m/f/d)

Deine Lehre als Fertigungsmesstechniker/Produktmessung (m/w/x)

Paid Diploma / Master's Thesis - Computational cleaning validation

Team Leader Automation m/f/d

Software Security Architect (m/f/d)

Senior System Security Architect (m/f/d)

Team leader electrical planning m/f/d

Embedded Senior Crypto Software Developer (m/f/d)

Senior Principal Engineer - PMIC IC Architect (d/m/f)

Deine Lehrstelle bei MAGNA Presstec in Weiz!

Supplier Quality Engineer Intern

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