Beschreibung
CSV Project Manager
8 month contract
Zuchwil
120 CHF - 130 CHF per day
Our client, a global lead in their industry, is seeking to appoint various Project Managers to assist on their current and upcoming rollouts regarding their CSV remediation's based in Zuchwil across various client sites. A the Project Manager our client requires a consultant with a keen eye for detail, a highly analytical nature and proficient with and in IT, MS Project is desired.
Key Responsibilities:
* providing guidance, project management and reporting activities related to Computer Systems Validation remediation activities
-Planning and implementation of qualification/validation activities and projects of existing computer systems according to procedures and regulations
-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
* 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.).
Key Requirements:
*English and German Fluent
*7-10 years experience with
*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
*Higher Education
*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.
Please email for further information or call to discuss further