Quality Assurance Associate - Aseptic Manufacturing

Summary: The Quality Assurance Associate role at a leading biopharmaceutical company in the Bern area focuses on providing compliance oversight in aseptic manufacturing and GMP environments. The position involves advising teams, managing deviations, and ensuring adherence to GMP standards without direct involvement in production or laboratory work. The role is advisory and quality-focused, with opportunities for skill expansion in deviation management and compliance. The contract is for 12 months with the possibility of extension, and partial remote work is available after onboarding.

Key Responsibilities:

• 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, including initial assessments and investigation strategies
• 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

Key Skills:

• 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

Salary (Rate): undetermined

City: Bern

Country: Switzerland

Working Arrangements: hybrid

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other