QUALITY & COMPLIANCE MANAGER/ DIPLOM CHEMIKER/ INGENIEUR/ GMP QUALITÄTSBEAUFTRAGTER/ Auditor/CSV
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- 4052 Basel
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- 13.09.2019
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
6/2019 – offen
Tätigkeitsbeschreibung
- Validation and qualification of equipment/ laboratory equipment
(construction and relocation of GMP regulated laboratories)
- Development of validation and qualification strategies
- Creation of test scripts for OQ and PQ
- Planning and implementation of all computer-aided system
activities including documentation according to the business and regulatory requirements (incl. GAMP5)
Softwaredokumentation, GXP, MS Office (Anwenderkenntnisse), DIN EN ISO (allg.), Dokumentenmanagement, Good Manufacturing Practices
7/2018 – 12/2018
Tätigkeitsbeschreibung
-Qualification and Validation of Hazard assessments of hydrogen-powered pilot plants (ISO 12001) and Chemicals
- Implementation and Organization of safety-relevant reconstruction measures (ISO 14001, 45001)
- Development of SOP‘s for individual work areas (high-pressure autoclave, calcination furnace)
- Supervision of master students in plant construction and other chemical issues
- Lab Safety Manager
- Documentation and execution of further research tasks
MS Office (Anwenderkenntnisse), Projekt-Qualitätssicherung, DIN EN ISO (allg.), DIN EN ISO 14001, Qualitätsdokumentation
10/2016 – 9/2018
Tätigkeitsbeschreibung
Managing Quality Control of Asian patents and paper - Quality assurance of the database REAXYS®
- Manage the administrative process of quality reports
- Coordination of external service providers
- Establishment of a table for the verification of word-
detection methods
- Control of links to internal databases - Correction of incorrect associations
- Correction of database entries
MS Office (Anwenderkenntnisse), DIN EN ISO (allg.), Qualitätsdokumentation, Dokumentenmanagement
5/2011 – 8/2014
Tätigkeitsbeschreibung
- Inorganic chemical analysis of glasses, glass ceramics and
raw materials
- Sample preparation for infrared spectrometry
Development and validation of new methods in wet chemical
analysis for pharmaceutical and Medical technology products
- Maintenance and qualification of laboratory and measuring
equipment
- Assistance in the qualification of the Reinstallation of a clean
room
- Evaluation of test results
- Support for all laboratory work
MS Office (Anwenderkenntnisse), DIN EN ISO (allg.), Qualitätsdokumentation, Dokumentenmanagement, Analytische Chemie
5/2006 – 9/2006
Tätigkeitsbeschreibung
- Quality Assurance, post-processing (form testing with laser tracker, measuring concave & flat glass surfaces)
- independent setup and operation of production machines Setting up production orders, drums, washing annealed parts, finishing (grinding), maintenance tools, testing by means of 3D measuring machines, Visual inspection and packaging
- Technical services (assembly of finished parts according to drawing, CNC programming)
Qualitätssicherungssysteme, Maschinen, Maschinenbau, Sondermaschinenbau, Werkzeugbau / Werkzeugmaschinenbau, Produktionstechnik (allg.)
9/1996 – 7/2005
Tätigkeitsbeschreibung- Construction book database
Eingesetzte QualifikationenMS Office (Anwenderkenntnisse)
Zertifikate
Ausbildung
Mainz
Weitere Kenntnisse
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Französisch (Grundkenntnisse)
- Europäische Union
- Schweiz
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