Senior QA Specialist (m/f/d)

Tasks :

• 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 requirement

• 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.

• 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, batch review, etc.).

Qualification:

• Academic background in a technical and scientific field (Master’s degree or equivalent – Bac +5)

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

• Holistic understanding of production processes (from cell culture to aseptic filling): 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 drafting documents in French and/or English

• Languages: French and English

• Minimum 4 days on-site

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

Requirements:

Start : 31.08.2025