Senior QA Expert (m/w/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