QA Specialist (f/m/d) – CSV & QV

In Bern, we’re launching a new production site and introducing innovative ways of working. This role supports our mission of high‑quality pharmaceutical products.

Responsibilities

• Develop, review and approve CSV and QV strategies, plans, protocols and reports for new and existing facilities, utilities, equipment, and computerized systems.
• Partner with cross‑functional teams such as Engineering, Manufacturing, IT, and other Quality services to ensure compliance and timely project execution.
• Participate in audits and inspections related to CSV and QV, ensuring readiness and robust documentation.
• Drive a culture of quality, compliance, and continuous improvement within CSV and QV activities, mentoring team members and stakeholders as needed.
• Support changes and corrections related to CSV and QV.
• Act as subject‑matter expert for relevant regulations and guidelines, including EU GMP (EudraLex Vol.4, Annex11 &15) and FDA...