QA Manager in Qualification & Validation (EW)

Basel-Stadt  ‐ Vor Ort
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Beschreibung

QA Manager in Qualification & Validation (EW) - CSV / Quality Management / German

Project / Role:
For our customer, F. Hoffmann La Roche in Kaiseraugst, we are looking for a highly motivated and qualified QA Manager in Qualification & Validation.
Background:
The Qualification & Validation department is part of the Quality Systems & Validation organization of the Kaiseraugst Quality Unit and provides support as Technical QA for, among others, Sterile Manufacturing, Packaging & Warehouse, Warehouse and Logistics, Quality Control, Engineering and Manufacturing IT in Kaiseraugst. As Quality Assurance (QA) Manager you will support the qualification and maintenance activities including CSV for one area of ??the site and will be the direct contact person.
Perfect candidate:
You are open to new ideas and question conventional patterns of thinking. You appreciate working in a performance-oriented environment based on mutual respect, discussion and intensive cooperation. You are a communicative and decisive personality with persuasive power and assertiveness who enjoys working independently.
Main Tasks:
-Performing quality assurance tasks in the (re) -qualification of production facilities, infrastructure and laboratory equipment as well as the validation of computer-aided systems (CSV)
-Support in the preparation of CSV and qualification documents
-Approval of qualification and validation documents and other GMP-relevant documentation
-Processing and approval of deviation reports (deviation management)
-Processing and approval of change requests (change control)
-Processing and approval of risk analyzes (risk management)
-Support / advice on qualification and validation projects in the various areas at the Kaiseraugst site
-Support as QA or expert within the scope of inspections by authorities and internal audits / self-inspections
Professional requirements:
-A degree or training in the technical / scientific field (eg engineering)
-At least 3 years' experience in the field of plant qualification and / or Computer system validation
-At least 3 years of experience in quality management (change control, CAPA, risk management)
-Experience in the application of Trackwise
-Very good knowledge of German spoken and written.
Personal requirements:
-very good communication skills
-strong team player
-Resilience
-Quick comprehension
Nice to Haves:
-Roche Experience

Reference: 919249NC
Role: QA Manager in Qualification & Validation (EW)
Industry: Pharma
Location: Kaiseraugst, Switzerland
Workload: 100%
Start date: 01.06.2020
End Date: 12months +

If this position has aroused your interest, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile very well and you wish to receive other positions directly, you can also send us your dossier via this advertisement or to jobs [at] itcag [dot] com.
Contact us for further information about our company, our positions or our attractive payroll-only program: .
About us:
ITech Consult is an ISO 9001: 2015 certified Swiss company with offices in Germany and Ireland. ITech Consult is specialized in the placement of IT candidates for contract work. Founded in 1997 by IT professionals, we know how important professional support in project search and work is
Start
06/2020
Von
ITech Consult AG
Eingestellt
14.04.2020
Projekt-ID:
1919359
Vertragsart
Freiberuflich
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