Job Summary

Support the Quality Management System (QMS) and Compliance activities withing the Biopharma Quality organization by assisting with documentation processes, and continuous improvement initiatives.

Responsibilities/Duties:

Act as eDMS key user and Trainer for electronic Quality Management Tools:

• Support assuring documentation & compliance;
• Collaborate with cross-functional teams to ensure timely execution of QMS deliverables;
• Support in implementation, distribution and archiving of Fresenius Kabi instructive documents, such as SOPs, Guidelines, Policies, Manuals, Working Instructions;
• Support collection of Key Performance Indicators for periodic review of local QMS.

Support the Quality team by monitoring CMO mailbox and responding to quality-related inquiries:

• Collect and process Events, Changes, CAPAs liaising with the relevant functions of the Business Unit, Production Units (PUs) and Suppliers.

Support continuous improvement of QO/QM processes associated to Document Management, Inspection Readiness, Supplier Management, Change Control / Events, CAPAs.

Qualification/Technical Skills:

• Understanding of GMP principles and regulatory expectations in Biopharma;
• Excellent communication skills in English, both written and oral, knowledge of French and German are an asset;
• Demonstrated ability to work effectively in a team;
• Excellent planning and organization skills, detail- oriented working style;
• Flexibility to switch between projects;
• Ability to organize, lead and synthetize meetings with internal and external parties;
• Goal Orientation / Commitment to Task / Follow-up;
• Highly interested in computerized systems and digitalization;
• Experienced in Office 365 applications;
• Attention to detail, analytical mindset, Problem Solving & Analytical thinking, Nimble Learning.

Education:

• A BA/BS, MA/MS a scientific discipline or related field.

Internship