Lead quality excellence at the forefront of Switzerland's next-generation Fill‑Finish and Visual Inspection operations.
Proclinical is seeking a QA Expert to join a team in Switzerland. This role focuses on supporting the implementation of a new F&F (Fill‑Finish) and VI (Visual Inspection) area within a pharmaceutical manufacturing site. You will also contribute to routine GMP operations, ensuring compliance with current guidelines and regulatory requirements. On‑site presence is expected, with occasional remote work possible for specific tasks.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities
* Prepare, evaluate, and approve controlled documentation creation and revisions.
* Review deviations related to production events within quality systems (e.g., Trackwise) to ensure adherence to procedures and regulatory standards.
* Conduct or approve investigations, impact assessments, and define relevant CAPAs.
* Attend meetings pertinent to quality assurance tasks.
* Approve aseptic interventions performed during Aseptic Process Simulations.
* Review Master Batch Records and ensure adherence to escalation processes.
* Complete relevant training and manage software access in line with company policies.
* Support continuous improvement initiatives, GMP tours, and other quality oversight tasks as needed.
Key Skills and Requirements
* Academic background in technical or scientific fields.
* Operational experience in cGMP environments, particularly in sterile injectable pharmaceutical production.
* Comprehensive knowledge of production processes, including cell culture, aseptic filling, gowning, environmental controls, and laboratory testing.
* Familiarity with cGMP quality standards and systems such as Deviations, CAPA, Change Control, and Documentation.
* Strong writing skills in French and/or English.
* Proficiency in Microsoft Office and PC-based work.
* Teamwork, adaptability, and autonomy.
* Fluency in French and English.
If you are having difficulty in applying or if you have any questions, please contact Joshua Bye at j.bye@proclinical.com.
Apply Now
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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