Auftrag A4319 - Projekt Manager Bereich GAM5 FDA (contract)

Beschreibung

Projekt Nr.: A4319 S
tartdatum: 01.04.2014
Branche: Dienstleistungsunternehmen
Dauer: 9 Monate mit Option
Einsatzort: Zürich, Basel, Bern oder Lugano
Publiziert am: 13.03.2014

https://www.ghrgroup.ch/projekt-details/orderNr/A4319.html

Beschreibung
Für unseren Kunden suchen wir mehrere sehr erfahrene Projekt Manager Bereich GAMP5 FDA für mehrere Standorte wie folgt:
Main Tasks

? 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

Computer System Validation

? - Planning and implementation of qualification / validation activities and projects of existing coputer systems according to Software Development Lifecycle as outlined in 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)
Extended Duties

? Planning, coordination and execution of activities in cross-plant projects (eg. qualification of IT systems and infrastructure needs, validation of software, etc.).

Must Skills

? Higher education (Engineer or similar)
? Background in IT and at least 7 years work experience in project management
? Responsibility in similar management position or extended experience as executer
? Strong knowledge of the Medical Device industry
? 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)
? Excellent communication and cooperation skills
? English fluent & Italian / German fluent depending on location

Anforderungen

? Projektleiter ein Muss

Sprachen

?Englisch sehr gut sehr gut ein Muss
?Italienisch sehr gut sehr gut von Vorteil
?Deutsch gut gut von Vorteil

Wir freuen uns auf Ihre Bewerbung

André van Sprundel
CEO

GHR Global Human Resources AG
Blegistrasse 13
CH-6340 Baar / ZG

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