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.)

Qualifications

• 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 ...