Senior QA Expert (m/w/d)

Senior QA Expert (M/F/D)

The objective of this resource within the Quality Ops organization is to provide support as a Quality Assurance Senior Expert 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.

Tasks :

• 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

• 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:

• Technical and scientific academic background (Master’s degree or equivalent)

• 2–3 years of operational cGMP experience in a Quality Operations department within a pharmaceutical manufacturing site producing sterile injectable products

• Holistic knowledge of manufacturing processes (from cell culture to aseptic filling), including unit operations, equipment, gowning, 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

• Proficiency in PC use and Microsoft Office

• Team-oriented mindset

• Agility and autonomy

• Minimum of 4 days on site

• Reporting to the QA Manager, with daily interaction with Manufacturing, Engineering, Sterility Assurance, Quality Operations, Training, etc.

• 2-shift (2×8) schedule to be expected during aseptic process simulation (APS) testing

Requirements:

Start : either 01.03.2026 or 01.04.2026

Duration : 30.09.2026