QA Expert Senior
- Neuchâtel
- CDD
- Temps-plein
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.This resource will be specifically responsible for the following 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.
- 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, batch review, etc.).
Home office might be allowed occasionally for specific tasks upon request.
EducationMaster's degree or equivalent (Bac+5) in a scientific or technical field - specialization in biotechnology, process engineering, or pharmaceutical quality. Professional Experience2 to 3 years of hands-on experience in a GMP-regulated environment, ideally within a Quality Operations department on a sterile injectable pharmaceutical manufacturing site.Work experience in classified cleanrooms, knowledge of EU/US GMP requirements, and strong understanding of aseptic filling processes. Technical SkillsHolistic understanding of production processes:
→ Cell culture, fermentation, purification, formulation, aseptic filling.
→ Familiarity with environmental monitoring, gowning procedures, microbiological and particle monitoring.
→ Understanding of QC testing - both physicochemical and biological.Proficient with Quality Systems:
→ Deviations, CAPA, Change Control, Training, Documentation.
→ Active participation in internal and external audits. LanguagesFluent in French and English (written and spoken). Digital SkillsProficient in PC use and the Microsoft Office suite (Word, Excel, PowerPoint, Outlook). Soft SkillsStrong teamwork abilities.Agile, autonomous, and adaptable in a dynamic environment.