Quality Assurance Associate – Aseptic Manufacturing

Location: Bern area

Workload: 100%

Contract type: 12-month contract (extension possible)

Start: Ideally 01/07/2025

Remote work: Partial remote possible after onboarding

On behalf of our client, a leading biopharmaceutical company, Swisslinx is looking for a Quality Assurance Associate with experience in aseptic manufacturing and GMP environments.

You will support the aseptic production area by providing compliance oversight, handling deviations, and ensuring GMP standards are met. The role is advisory and quality-focused — no hands-on work in the production or laboratory is required.

• Support and advise aseptic manufacturing and microbiology lab teams (no direct production or lab work)
• Ensure GMP compliance in production processes
• Review, control, and document aseptic production steps
• Participate in training and (re)qualification of production staff
• Support deviation management for aseptic filling:
  • Perform initial assessments
  • Assist in defining investigation strategies and reviewing technical assessments
  • Help operations investigate deviations and define effective CAPAs
  • Review investigation reports (German and English) with a focus on compliance and risk
• Support internal and external inspections with deviation documentation
• Review specification and procedural documents

• Experience in aseptic manufacturing or quality oversight in a GMP environment
• Strong understanding of deviation handling and CAPA processes
• Excellent communication and documentation skills in German and English
• Degree in Life Sciences or related field preferred
• Precise, structured, and reliable working style with a team-oriented mindset

• A chance to work in a high-impact QA role in one of Switzerland’s leading pharma companies
• A dynamic and collaborative team environment
• Opportunities to expand your skills in deviation management and compliance