Beschreibung
REFERENCE: JNJ
ROLE: PROJECT MANAGER
SKILLS: CSV, GXP, Project Management, PMI, Medical Device, MS Projects
LOCATION: Switzerland, Raron CHE 3942
HOURS: Per day 8 hours, Hours per week 40, 6 month contract
EXTRA: English and German written and spoken
My client is looking for a Project Manager with a strong knowledge of the Medical Device industry is required.
You will be providing guidance, project management and reporting activities related to Computer Systems validation remediation activities
You must have a background in Quality Systems is required, as the procedures to revise are related directly to the quality of the product or the quality system of the manufacturing.
You will need:
Knowledge of regulation as defined by ISO and FDA is desired
Computer System Validation:
- Planning and implementation of qualification/validation activities and projects of existing computer systems according to J&J Software Development Lifecycle as outlined in Synthes Procedures.
- Support and consulting during projects handling GxP critical computer systems
Project Management (and all PM deliverables)
System Test script writing and execution/Application Installation Scripts
UAT Testing
System Management Plan
Writing of Work Instructions/Procedures
Security Deliverables as required
BIA and Disaster Recovery Plan/Report (if applicable)
Extended Duties:
- Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).
Requirements:
- Higher education (Engineer or similar) and background in IT and at least 7 years work experience in project management.
- Responsibility in similar management position or extended experience as executer required. Knowledge of national and international regulations and standards, eg. GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
Minimal language skills:
English & German fluent
- Bachelor Degree in Mathematics, Engineering, Computer Science OR equivalent through experience. Advanced course work in technical systems plus continued education in technical disciplines is preferred; - Additional PMI certification is a plus; Language
- proficiencies: -English spoken and written;