IT CSV Consultant & Project Manager

Salzburg  ‐ Onsite
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Keywords

Description

Für ein renommiertes Unternehmen aus der Medizintechnik suchen wir einen IT CSV Consultant & Project Manager für Österreich, Salzburg.

Project Manager
* 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. Development Lifecycle as outlined in the Company Procedures.
- Support and consulting during projects handling GxP critical computer systems
- Approving 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
-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 running / Application Installation Scripts
* System Management Plan
* Security Deliverables as required
* BIA and Disaster Recovery Plan/Report (if applicable)
-will possibly be engaged in working with the migration of payroll and HR.
-Also possible to contribute to the infrastructure integration 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.

Minimal language skills: English & German fluent (spoken and written) is a Must

Für mehr Informationen über Real, besuchen Sie www.realstaffing.com
Start date
03/2014
Duration
7 Monate
From
Real Staffing
Published at
02.04.2014
Project ID:
688119
Contract type
Freelance
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