102 offres d'emploi dans Biologie / Biotechnologie

Enregistrer un JobMailer
1 / 6
QA consultant Process validation Biopharma
AXEPTA SA - Vaud
23.05.2019 | Employé | 100%

QA consultant Process validation Biopharma

My client is a growing pharmaceutical company based in the French part of Switzerland looking to expand their quality team.

Due to this growth, my client is looking for a Quality Project Manager with strong experience with biologics to join their team for a mission of 6-7months.

Responsabilites :

  • Manage oversight of the quality of International CMOs involved in API manufacturing
  • Direct the quality process Validation activities
  • Ensure compliance of the company's product by reviewing, approving and ensuring maintenance of
Material and Product specifications
  • Ensure and monitor implementation of Changes at assigned CMOs
  • Ensure and monitor implementation of CAPA at assigned CMOs
  • Manage Manufacturing deviations
  • Perform Batch Record Reviews and releases,
  • Perform external and internal audits
  • Participate to the elaboration of APR and PQR and coordinate collect of data with assigned CMOs.
  • Manage API shipping validations in collaboration with Supply chain teams
  • Manage Quality and Technical Agreements with assigned CMOs
  • Contribute to define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to manufacturing;
  • Participate to the inspection readiness
  • Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements
  • Interpret GMP, general regulatory requirements and Quality systems GMP regulations and ensure implementation as applicable

Your Profile :

  • Academic degree in Chemistry or Pharmacy;
  • Experience of minimum 5 years in Quality Operations in API manufacturing for international pharmaceutical industry, ideally acquired at a biomanufacturing site
  • Experience with quality process validation
  • Thorough knowledge in cGMP and global regulatory requirements;
  • Experience in Validation and tech transfers;
  • Must be fluent in English

Ce site web utilise des cookies afin d'offrir le meilleur service possible. Pour plus de détails, consultez nos Conditions générales et nos informations sur la Protection des données.