Beschreibung
Project Manager
Edelway AG is a Professional Services Consultancy based in Switzerland.
One of our best clients, a global biopharmaceutical company, based in the Basel area, is currently looking for a Project Manager to join them on a long-term basis.
Language: Fluent in English and German.
Start Date: ASAP
Excellent rate paid per hour.
The role:
The project manager will be providing guidance, project management and reporting activities related to Computer Systems validation remediation activities.
Main Activities:
*Planning and implementation of qualification/validation activities and projects of existing computer systems.
*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
Your profile:
*Strong knowledge of the Medical Device industry is required.
*Experience in leading project teams is required.
*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.
*Fluent English and advanced German.
If this sounds like your next challenge send me your CV to Paula and I will call you to discuss the role in more details.