Description
We are looking for a
Validation / Qualification Engineer Med. Tech + Pharma (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Place: in Schleswig-Holstein
Branch: Unternehmensberatung
Your tasks:
- Devise qualification protocols (installation, operational and performance) as well as Media Fill Protocols
- Devise Validation Master Plan, Process Validation
- Devise Cleaning Validation, Clean Room qualification
- Provide calibration services
- Provide technology transfer, Process Analytical Technology (PAT) support
- Temperature mapping
- Planning and status update, issue tracking and management
- Regulatory exposure warning
- Devise resource capacity plan
Your qualifications
- Experience in FDA QSR
- Experience in GMP (Good manufacturing practice)
- Knowledge of ISO 13485
- Lean experience + Six Sigma experience
- Medical devices experience + pharma experience
Skills:
- Qualification/validation specialist
Keywords: Validation Validierung Qualifizierung Qualification MedTech Pharma Testmethod Testmethoden ISO FDA QSR GMP Lean Six Sigma. Project Management Spezialist Validierung und Qualifizierung