Senior Quality Assurance Specialist

Responsibilities

• 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.)

• 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
• Agility and autonomy

• 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