Beschreibung
REFERENCE: JNJ
ROLE: PROJECT MANAGER
SKILLS: Project Management, MS Project, Quality Systems,
LOCATION: Various Locations Switzerland (Zuchwil, Zug, Selzach etc)
EXTRA: English & German Written and Spoken
My client is looking for a Project Manager who has a strong knowledge in Medical Device industry.
You must have:
Experience in leading project teams is required
The project manager will be providing guidance, project management and reporting activities related to Computer Systems validation remediation activities
Knowledge in MS Project is desired.
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.
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
- CSV remediation activities to be coordinated in cooperation with a QA CSV lead
- support the IT deliverables for the CSV remediation
- These SDLC deliverables include:
Project Management (and all PM deliverables)
Detailed Design - Technical Design Spec
System Test script writing and execution/Application Installation Scripts
System Management Plan
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
- Familiarity with med. device manufacturing plants, SDLC (prefer J&J but can be flex).
Minimal language skills:
- English & German fluent