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QA consultant Process validation Biopharma
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

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