Weitere Details
Quality Assurance Associate m/f/w (DE)
[17095]
GMP, Sterile Produkte
As a Quality Assurance Associate, you will report directly to the Quality Assurance Supervisor and play a key role in ensuring compliance and quality oversight throughout the manufacturing process. You will act as the primary QA representative on the shop floor for routine GMP activities within the Bulk Drug Substance and Aseptic Fill & Finish production areas. Working closely with operational teams, you will help ensure the production of high-quality biological products while proactively identifying improvements and mitigating compliance risks. Project title: Quality Assurance Associate m/f/w Type of employment: Payroll Industry: Biotech Skills: GMP,Sterile Produkte Project start: 02.03.2026 Project duration: 6 months Location: Neuchâtel, Switzerland Tasks: ·Review production-related documentation (e.g., batch records) directly in the manufacturing areas. ·Observe critical activities on the shop floor and support real-time issue resolution. Provide continuous QA presence and collaborate with production teams to implement actions ensuring product quality. ·Support GMP compliance and adherence to internal procedures by maintaining a strong partnership between Quality and Operations. ·Coach operational teams in event management and quality decision-making. ·Collaborate with shop-floor teams to support problem-solving and root cause identification for deviations. ·Perform planned and unplanned Gemba walks to ensure process adherence and identify improvement opportunities. ·Serve as the QA point of contact for all quality-related questions in the production area. ·Proactively identify potential quality risks in collaboration with production teams. Qualifications: ·Fully proficiency in French ·2–3 years of experience in a cGMP environment within Quality Operations or Manufacturing on a pharmaceutical site producing sterile injectable products. ·Strong understanding of production processes (from cell culture to aseptic filling), including unit operations, equipment, gowning, environmental monitoring, etc. ·Strong motivation and genuine interest in working directly in production areas.
- Review production-related documentation (e.g., batch records) directly in the manufacturing areas.
- Observe critical activities on the shop floor and support real-time issue resolution. Provide continuous QA presence and collaborate with production teams to implement actions ensuring product quality.
- Support GMP compliance and adherence to internal procedures by maintaining a strong partnership between Quality and Operations.
- Coach operational teams in event management and quality decision-making.
- Collaborate with shop-floor teams to support problem-solving and root cause identification for deviations.
- Perform planned and unplanned Gemba walks to ensure process adherence and identify improvement opportunities.
- Serve as the QA point of contact for all quality-related questions in the production area.
- Proactively identify potential quality risks in collaboration with production teams.
- Fully proficiency in French
- 2–3 years of experience in a cGMP environment within Quality Operations or Manufacturing on a pharmaceutical site producing sterile injectable products.
- Strong understanding of production processes (from cell culture to aseptic filling), including unit operations, equipment, gowning, environmental monitoring, etc.
- Strong motivation and genuine interest in working directly in production areas.
Tünde Verebélyi