Quality Assurance Expert
Quality Assurance Expert
QLS are recruiting for a Quality Engineer to join an global pharmaceutical company based in Neuchatel on a contract basis until for 8 months.
Home office : 1-2 day home office.
Services : The objective of this resource within the Quality Ops organization is to provide support as a Quality Assurance Expert in the frame of routine GMP operations.
He / she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements.
The person will be specifically responsible for the following tasks :
Review deviations in the framework of engineering 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.
- Review and approve Engineering controlled documentation being revised.
- Review and approve requalification of Cleaning in place / sterilization in place / Temperature control unit and review / approve protocol deviations related to.
- Perform the assessment of change control from a Quality Engineering standpoint.
- 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 of technical area, etc.).
Profil recherché :
- Formation académique technique et scientifique.
- 2-3 ans d’expériences opérationnelles cGMP dans un département Qualité Ops ou Engineering sur un site Manufacturing de l’Industrie Pharmaceutique, biotechnologies et / ou produits stériles injectables.
- Connaissance des référentiels Qualité (cGMP) et des Systèmes Qualité (Déviations, CAPA, Change Control, Training, Documentation, etc.).
- Connaissances techniques maintenance, facilities / utilities, HVAC, calibration serait un plus.
- Capacité rédactionnelle pour des documents en français et / ou anglais, et lecture des documents en français et Anglais.
- Langues : français et anglais.
- Travail sur PC et connaissances pack Microsoft.
- Travail en équipe.
- Agilité et autonomie.
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