Senior QA Associate

Senior QA Associate (80–100%, permanent) –

Location:

Schaffhausen, Switzerland.

• QA responsibility for multiple products.
• Independent management of projects, e.g., establishment and reorganization of specific areas, process improvements, introduction of new techniques, including within international teams.
• Handling, tracking, and ensuring timely closure of non-conformances.
• Advising other departments such as Production, Planning and Engineering in a GMP environment and supporting the implementation of improvements.
• Ensuring GMP‑compliant processes and documentation.
• Reviewing batch documentation of manufacturing processes and releasing batches for further processing and final release.
• Reviewing and approving quality‑relevant master data for materials.
• Supporting Production on quality‑related issues, including regular walkthroughs/plant rounds.
• Supporting inspections and audits; acting as subject‑matter expert (SME) for selected areas.

• Degree in a scientific or technical field.
• More than 5 years’ professional experience in Quality Assurance or pharmaceutical manufacturing.
• Experience with NC/CAPAs and CoCs required; experience with supporting tasks such as Risk Assessments, Smoke Studies, etc. appreciated.
• Background in aseptic manufacturing, hygiene, or microbiology is a definite plus.
• Comprehensive knowledge of relevant regulations.
• Excellent German and English communication skills (written and spoken).
• Confident user of MS Office;
  GenAI and Copilot.
• Solution‑oriented, independent, and a team player.