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Senior QA Expert (M/F/D)
Tasks:
Approve on the floor aseptic interventions performed by manufacturing during Aseptic Process Simulation
Review Master Batch Records
Attend all meetings relevant to perform the above-mentioned tasks
Respect the escalation process
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.)
Qualification:
Experience with Aseptic Process Simulation and batch review (in PAS-X system if possible)
Technical and scientific academic background (Master’s degree or equivalent, Bac +5)
2–3 years of operational cGMP experience within a Quality Operations department on a pharmaceutical manufacturing site producing sterile injectable products
Holistic knowledge of production processes (from cell culture to aseptic filling): unit operations, equipment, gowning procedures, environmental monitoring, physicochemical and biological laboratory 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
Computer proficiency and knowledge of the Microsoft Office package
Teamwork skills
Agility and autonomy
Working mode:
Minimum 4 days on site
Reporting to the QA Manager, with daily interaction with Manufacturing, Engineering, Sterility Assurance, Quality Operations, Training, etc.
A 2-shift schedule (2x8) to be expected during aseptic process simulation tests
Requirements:
Start: 16.03.2026
Duration: 4 months
Capacity: 5 days per week
Location: Neuchatel, Switzerland
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