Beschreibung:

For our client, a world leading pharmaceutical company located in canton Lucerne we are looking for a high qualified Quality Control Specialist for supporting the quality responsible persons in their oversight of the quality management system (QMS) and the associated processes – CiC to spin-off.


Location: Area of Lucerne, Switzerland
Start date: as soon as possible
End date: At least until spin off date

Your Challenges
For this position we are looking for a qualified person to support in all aspects of Documentation administration and related systems migration / set-up, for the archival of documentation and for the related training to personnel. In detail:

Implementation of documental changes

Establish / migrate SharePoint with links for direct access 

Support with project documentation (plan, reports)

QMS Document preparation for migration 

Archiving Routine upload of documentation Maintenance of Trackersadministration of quality documents

Quality Agreements Maintain trackerSupport duplication and adaptation for spin-off of Pan EU, Intercompany and global Quality agreements

Support from a documentation perspective in the management of the deviations, CAPAs and change control systems as well as internal audits, health authority inspections and quality metrics reporting, at the EMEA Supply Chain Hub

Support with KPIs reporting (deviations, CAPAs, changes, regulatory inspections, quality plan, internal audits, supplier / customer qualification) – to be set up

Support with set-up of training matrix, curricula and plan

Support the appointment of Systems/Sub-Systems Owners for Organon

Support establishment local procedure for the EMEA Hub

 
Your skills

English speaker (German a plus)

Pharmaceutical quality background (min 1-2 years) and quality docs writing skills

Experience with Documentation systems / SharePoint

Supply Chain experience is advantageous

Excellent organizational skills. Ideally project management experience.