SENIOR QA EXPERT
Duration: 01/08/2025 - 31/01/2026
Location: Neuchatel, CH
KEY RESPONSIBILITIES:
* Prepare, evaluate, and approve controlled documentation, creation/revision.
* Review of deviations in the framework of production events within quality systems (i.e. Trackwise) to verify acceptability and adherence to standard procedures and regulatory requirements.
* This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of relevant CAPA.
* Attend all meetings relevant to perform the above-mentioned tasks.
* Respect the escalation process.
* Ensure completion of relevant training and software access management.
* Other tasks related to conventional quality oversight might be occasionally requested to support the team (e.g. continuous improvement initiatives, GMP tour in classified areas, batch review, etc.).
KEY REQUIREMENTS:
* Academic background in a technical or scientific field (Master's degree or equivalent)
* 2-3 years of hands-on cGMP experience in a Quality Operations department within a pharmaceutical manufacturing site for sterile injectable products
* Holistic understanding of production processes (from cell culture to aseptic filling): unit operations, equipment, gowning, environmental monitoring, physico-chemical and biological lab testing, etc.
* Knowledge of Quality standards (cGMP) and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation, etc.)
* Strong writing skills for documentation in French and/or English
* Languages: French and English
* Proficient in PC use and Microsoft Office Suite
* Team player
* Agile and autonomous
WORK MODE:
* Minimum 4 days on-site (The above-mentioned tasks are site-based and on-site presence is expected. Home office might be allowed occasionally for specific tasks upon request.
* Reports to the QA Manager, with daily interaction with Manufacturing, Engineering, Sterility Assurance, Quality Ops, Training, etc
SThree_Germany is acting as an Employment Business in relation to this vacancy.