AVAILABLE Computer Systems Validation Specialist CSV, IT Quality Management, Technical Writing, Project Quality Manager PQM, GxP, GMP, 21 CFR Part 11
Aktualisiert am 13.06.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 10.06.2024
Verfügbar zu: 100%
davon vor Ort: 40%
Computerized System Validation
Project Quality
IT Quality
IQ
OQ
PQ
GxP
KNEAT
HP ALM
AGILE methodology
21 CFR
SDLC
Test script
Good Documentation Practice
Risk Assessment
FMEA
IT Control Frameworks
SAP Validation
Acceptance Test
Good Manufacturing Practice
Installation Qualification
Technical Documentation
CSV

Einsatzorte

Einsatzorte

Basel (+75km)
Schweiz
möglich

Projekte

Projekte

1 year 7 months
2021-12 - 2023-06

Veeva Vault QMS and Spotfire Dashboard upgrades and enhancements validation

Technical Writer and CSV Engineer csv KNEAT Testmanagement ...
Technical Writer and CSV Engineer

Subprojects included Distribution, Product Quality Complaints, Late Case Reporting, Engineering Docs, Issue Escalation, Batch Disposition.

Utilized KNEAT for document creation, test script execution, discrepancy management, and reviews. Employed ServiceNow for application change Control management.

Veeva Vault
csv KNEAT Testmanagement QMS
Moderna
Basel

Einsatzorte

Einsatzorte

Basel (+75km)
Schweiz
möglich

Projekte

Projekte

1 year 7 months
2021-12 - 2023-06

Veeva Vault QMS and Spotfire Dashboard upgrades and enhancements validation

Technical Writer and CSV Engineer csv KNEAT Testmanagement ...
Technical Writer and CSV Engineer

Subprojects included Distribution, Product Quality Complaints, Late Case Reporting, Engineering Docs, Issue Escalation, Batch Disposition.

Utilized KNEAT for document creation, test script execution, discrepancy management, and reviews. Employed ServiceNow for application change Control management.

Veeva Vault
csv KNEAT Testmanagement QMS
Moderna
Basel

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