Beschreibung
CSV Project Manager - IT - 9 Month contract - Basel
A huge Medical Device company based in Switzerland require a number of IT Project managers to join their Project on a contract basis.
Key Responsibilities:-
Strong knowledge of the Medical Device industry is required
The consultant will be providing guidance, project management and reporting activities related to Computer Systems validation remediation activities
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.
Computer System Validation:
Planning and implementation of qualification/validation activities and projects of existing computer systems according to Software Development Lifecycle as outlined in Procedures.
Support and consulting during projects handling GxP critical computer systems
Prepare and approve specific computer system validation documentation
Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations
These deliverables include:
Project Management (and all PM deliverables)
Requirements Identification and documentation
Detailed Design - Technical Design Spec
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
Familiarity with med. device manufacturing plants, SDLC