QA Expert

One of our clients in Neuchatel (Switzerland) is looking for a QA Expert to provide support in the frame of implementation of a new Fill and Finishing and Visual Inspection area. He/she could also be involve in routine GMP operations for Fill and Finishing area. He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements.

Please note for this job there is possibility of working on a 2×8 shift schedule for a few weeks during the assignment to support aseptic process simulation activities:

• 06:00 – 14:30
• 14:00 – 20:30

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.
• Approve on the floor aseptic interventions performed by manufacturing during Aseptic Process Simulation .
• Review Master Batch Records
• Ensure completion of relevant training and software access management according to Takeda policies.
• 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, etc.)

Requirements
:

• Technical and scientific academic background (Master’s degree / Bac +5)
• 2–3 years of cGMP operational experience in a Quality Operations department on a pharmaceutical manufacturing site for sterile injectable products.
• Knowledge of production processes (from cell culture to aseptic filling): unit operations, equipment, gowning, environmental monitoring, physico‑chemical and biological laboratory tests, etc.
• Knowledge of Quality standards (cGMP) and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation, etc.).
• Languages:
  
  French and English.

Location: Neuchatel

Duration: Temporary contract until 30/09/2026

Home Office: The above-mentioned tasks are site-based and on-site presence is expected. Home office might be allowed occasionally for specific tasks upon request.

* While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.

** Please note that we can only consider EU/Schengen applications