Project Manager - Computer System Validation (CSV ) Expert

Solothurn  ‐ Vor Ort
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Schlagworte

Beschreibung

Randstad IT Professionals is actively looking for Project Managers coming from Medical Device industry background for their client in Switzerland. 

Experience and Main Tasks:
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
The person must be analytical, thorough, accurate and proficient in the use of computers
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 the company`s Software Development Lifecycle as outlined in the 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
-CSV remediation activities to be conducted in cooperation with a QA CSV lead
- Knowledge in technical skills like Technical Writing is requested
- develop and support the IT and Business deliverables for the CSV remediation
-These SDLC 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)
.
-Also possible to contribute to the infrastructure qualification planning activities and possibly some of the execution based on timing.

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
Team Player, able to work in a flexible environment with diverse characters/instances with excellent communication and cooperation skills.

Main Language: English

Must be also fluent in one of the two : German or Italian
  

Start
keine Angabe
Dauer
8 months
Von
Randstad (Schweiz) AG
Eingestellt
15.05.2014
Projekt-ID:
706629
Vertragsart
Freiberuflich
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