Project Manager

Ticino  ‐ Vor Ort
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Schlagworte

Beschreibung

Project Manager

Start date: ASAP
Duration: 8 months
Location: Mezzovico
Languages: English and Italian

* Strong knowledge of the Medical Device industry is required
* 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
* 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 J&J Software Development Lifecycle as outlined in Synthes 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 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)
-Also possible to coordinate 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 (prefer J&J but can be flex).
Team Player, able to work in a flexible environment with diverse characters/instances with excellent communication and cooperation skills.

Minimal language skills:
English & Italian fluent

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start
31/12/2014
Dauer
8 months
Von
Michael Bailey Associates - Zurich
Eingestellt
19.03.2014
Projekt-ID:
681488
Vertragsart
Freiberuflich
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