Third Party Quality Assurance Specialist – API (f/m/d)

In this function you support third-party quality operations within an External Manufacturing Active Pharmaceutical Ingredients (API) Network. This role ensures that third-party APIs are manufactured and released according to specified requirements. Responsibilities include performing quality system tasks in the Veeva system, such as change control, deviations, audit CAPA monitoring, and documentation management. You also monitor and review GMP documents like Product Quality Reviews and quality agreements, and upon qualification, provide SAP support.

Tasks and Responsibilities

• Assist with quality-related tasks in the Veeva system (change controls, external deviations, CAPAs)
• Maintain documentation management in Veeva for various kinds of records
• Oversee the system that handles the annual receipt and review of external API Product Quality Reviews (PQR). Support Third-Party Management in reviewing supplier PQRs according to defined schedules
• Supervise and track the revision cycles of quality agreements. Follow up with internal and external stakeholders for necessary revisions
• With suitable qualifications and relevant prior experience, support SAP tasks and processes

Profile

• Work experience in a GMP environment (QA, Manufacturing of APIs, QC)
• Good understanding of GMP processes
• Good IT skills in general
• Experience with Veeva and/or SAP is a plus
• Very reliable and precise working method
• Technical writing skills in English
• Fluent in English, German skills are a plus

General information 

• Startdate: flexible (applicants with a notice period will also be considered)
• Planned duration : 1 – 2 years
• Place of work: Basel (hybrid)
• Workload: 80 - 100%

If you are interested in this position, please send your resume in English.