01.05.2024 aktualisiert
100 % verfügbar
CSV Consultant / CSV Quality Assurance Manager
Allschwil, Schweiz Master’s Degree in Business Engineering Management
Skills
21 CfrGood Manufacturing PracticesData MigrationDokumentenmanagementIso 13485ProjektmanagementRisikomanagement
A proactive CSV Manager specialized in data integrity throughout the data life cycle. Skilled in designing and executing qualification and validation processes within regulated GxP environments. Proficient in cGMP, GAMP 5, FDA 21 CFR Part 11 and 820, GMP EU Annex 11, and ISO 13485, adept at managing complex systems and processes. Strong communication skills in intricate environments, fostering collaboration and adaptability. Exhibits independence, accuracy, responsibility, and service orientation.
Fluent in English, with native German proficiency.
Knowledge Domains or Areas:
- GxP Compliance Lifecycle Document Management
- Data Integrity and Data Migration
- Project Management
- Quality and Risk Management
- Process Technology Engineering
Fluent in English, with native German proficiency.
Knowledge Domains or Areas:
- GxP Compliance Lifecycle Document Management
- Data Integrity and Data Migration
- Project Management
- Quality and Risk Management
- Process Technology Engineering
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
- Created GxP compliant documentation for IT infrastructure qualification and SAP S4/HANA OpenText validations.
- Authored SOPs for IT infrastructure, URS for applications, ICRA, VP, ERES, DS, FS, FRA, TRM, VR, IQ,OQ, PQ, UAT test scripts, and plans, such as test & strategy, migration plans and operationalhandbooks.
- Actively participated in CAPA and Deviation investigations, Change Management, and their closure.
- Conducted retrospective validations of the Eplan application with interfaces to SAP S4/HANA ensuring compliance with SOPs and Gamp 5.
- Authored VP, ERES, DS, FS, FRA, TRM, VR, IQ, OQ, PQ, UAT test scripts, and plans with reports.