Beschreibung
Projekt Nr.: A3548Funktion Specialist Quality Assurance (contract)
Branche Pharmaunternehmen
Pensum 100%
Arbeitsort Luzern
Antrittstermin sofort
Dauer 24 Monate mit Option
Anzahl Stellen 1
Stellenbeschreibung
http://www.ghrgroup.ch/projekt-details/orderNr/A3548.html
Für unseren Kunden suchen wir einen sehr erfahrenen Specialist Quality Assurance wie folgt (English):
Responsibilities:
Development / implementation and deployment of company-internal regulations (material releases, blocking, re-certification)
Development / maintenance of systems to ensure that the production, packaging, analysis, storage and distribution / delivery to internal company, government policies and in accordance with prior art
Control and monitor processes that are related to material life cycle
Development and improvement of systems for QA planning
Support for manufacturing, respectively. Product-related differences
Support for Out-of-specification investigations
Approval of master documents and batch documentation
Enable / disable / Recall of Raw Materials
Enabling / disabling of master and working cell banks
Share certificates of analysis for master and working cell banks, as well as for drugs
Enable / disable / Recall of pharmaceutical drugs
Conduct recertifications
Optimisation of systems for enabling / disabling / recall of drugs.
Where possible, according to regulations:
Permit the shipment of unapproved drugs and intermediates
Permission to use the risk of partially or non-shared material for the biotech sector.
Investigations for the processing of biologics
Processing of changes in the field of biologics
Support for recall i.e., All actions resulting from a recall
implementation of SOP review and implementation of the QA release
Requirements:
Min Education BSc or Technical University in Life Sciences
Min 3 to 5 year of experience in GMP environment (ideally Biomanufacturing)
Ideally Quality Assurance experience
Candidates with strong GMP experience with no QA to be considered
Team-oriented and open personality
Diverse Tätigkeiten gemäss Projektleiter
AnforderungenIT Profil Priorität
Quality Assurance ein Muss
Qualitätsmanager ein Muss
SprachenSprache mündlich schriftlich Priorität
Englisch sehr gut sehr gut ein Muss
Deutsch sehr gut sehr gut ein Muss
Wir freuen uns auf Ihre Bewerbung
André van Sprundel
CEO
global human resources group
Blegistrasse 13
CH-6340 Baar / ZG
Tel:
Direktnr:
Fax:
E-Mail:
Web: http://www.ghrgroup.ch
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