Senior QA Specialist, Bioconjugates 80-100% (f/m/d)
Core
Senior QA Specialist responsible for establishing and maintaining the Quality Management System for Bioconjugates manufacturing, ensuring operational compliance and driving continuous improvement.
Role type
Senior IC Quality Assurance Specialist (Pharmaceuticals/Bioconjugates)
Builds
Bioconjugates pharmaceutical products
Domain
Life Sciences / Biologics Manufacturing / GMP
Required skills
GMP compliance, Deviation management, CAPA management, Change Request management, SOP authoring and review, Risk assessment, Stakeholder management, Training and coaching
Preferred skills
Green Belt certification, Health authority interaction experience (Swissmedic, FDA), TrackWise, SAP, Microsoft Office, QA trainer experience
Technologies
TrackWise, SAP, Microsoft Office
Responsibilities
Support continuous improvement programs to establish effective Quality Management System; Partner with cross-functional teams to identify risks and drive deviation management; Guide stakeholders to ensure robust quality culture and operational compliance; Manage and participate in 'QA on the floor' program including walkdowns; Act as QA SME in audits and inspections; Review and release records like SOPs, Deviations, and Change Requests; Identify emerging QA topics and develop new quality strategies; Train and coach new and existing QA Specialists.
Seniority
Senior, hands-on IC
