Quality & Compliance Intern (m/f/d)

206030 Fresenius Kabi SwissBioSim GmbH; Eysins; On-site; CHF 90,000 - 130,000; Full time

Job summary

Fresenius Kabi USA seeks a Quality Documentation Specialist to support the QMS and compliance activities within the Biopharma Quality organization. You will assist with documentation processes, training, and continuous improvement initiatives to ensure regulatory alignment.

Key tasks include acting as the eDMS key user and trainer, coordinating SOPs, guidelines, and archived materials, and collecting KPI data while liaising with Production Units, Suppliers, and internal teams.

Qualifications

• Understanding of GMP principles and regulatory expectations.
• Excellent communication in English; French and German are an asset.
• Demonstrated ability to work effectively in a team.
• Excellent planning and organization skills, detail-oriented.
• Flexible to switch between projects.
• Ability to lead and synthesize meetings with internal and external parties.
• Goal orientation and follow-up.
• Interest in computerized systems and digitalization.
• Experience with Office 365 applications.

Responsibilities

• Act as eDMS key user and trainer for electronic Quality Management Tools.
• Collaborate with cross-functional teams to ensure timely execution of QMS deliverables.
• Support distribution and archiving of SOPs, Guidelines, Policies, Manuals, Working Instructions.
• Collect KPI data for periodic local QMS reviews; liaise with Business Units, Production Units, and Suppliers.
• Support continuous improvement of QMS processes related to Document Management, Inspection Readiness, Supplier Management, Change Control / Events, CAPAs.

Skills

GMP knowledge

English communication

Team collaboration

Planning & organization

Digitalization interest

Office 365

Meeting facilitation

eDMS familiarity

Education

Bachelor's degree in a scientific field

Tools

eDMS

Office 365

Job description

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

When your job has both impact and purpose, you know it's Fresenius. As a global healthcare group, we are committed to a special goal: Ever better medicine for ever more people. Whether directly with patients or as an expert in the background, at Fresenius you can contribute to improving the quality of life of people with diseases.