Beschreibung
We are looking for a
Project Manager for Computer System Validation (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM++
Ort: in Baden-Württemberg
Branche: Herstellung von medizintechnischen Apparaten und Materialien a. n. g.
Ihre Aufgaben:
- Project management for cross plant projects related to computer system validation
- Handling GxP critical computer systems
- Support the SDLC Software Development Life Cycle (Detailed Design, Script writing, management plan, security deliverables, BIA and disaster recovery)
- CSV remediation activities
- Approving specific computer system validation documentation
- Planning and implementation of qualification / validation activities
Ihre Qualifikation
- Engineer Degree or similar
- Profound experience in Computer System validation (CSV) and SDLC (systems development life cycle)
- Profound experience in Project Management
- Profound experience within Medical Devices Industry
- Profound experience in Quality Management / Quality Management Systems
- Solid experience with GxP, GAMP5, ISO 13485, ISO 62304, FDA QSR, 21CFR Part 11,
- Solid experience with Project Management Tools such as MS Project
Skills:
- Quality manager
- Auditor
- Qualification/validation specialist