Sr QA Engineer (m/f) - Biotechnology

Our client is fast-growing biotech company near Neuchâtel.

Responsibilities:

• Interact with manufacturing and development teams to support process development for investigational product delivery as Quality referent;
• Collaborate with manufacturing team regarding raw material management for project planning progress;
• Coordinate and performs batch record disposition for manufactured products for phase I/II clinical trials support;
• Perform quality evaluation of investigational reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending;
• Review and approve deviations, CAPA’s, change controls and quality control;
• Participate in project teams to support GMP compliance for every project;
• Provide cGMP and associated OJT training to QA and other departments to improve right the first time (RFT), high quality performance.

Profile:

• Master’s degree or equivalent in life sciences
• Justify at least 5-8 years of experience in a QA Operation position within biopharmaceuticals or equivalent;
• Good knowledge of US, EU, PIC/s cGMP guidelines;
• Good experience with QMS to include, Batch Record design/review and supporting investigations;
• Fluent English is required, French is highly desirable.