Description
A global pharmaceutical company is looking for Quality Management Systems Specialists to support the transformation of a chemical site into a biopharmaceutical manufacturing site.Project:
• Take part in gap analysis of their existing Quality Management System onsite to determine which changes will be necessary to bring it in line with GMP regulations.
• They are looking for individuals who can implement the necessary changes to update the QMS.
Role and Responsibilities:
• Determine which protocols will be necessary to fill the gaps in the existing QMS to achieve GMP compliance
• Revise and write new SOPs to ensure that the correct steps are taken to ensure GMP compliance.
• Generate work flow diagrams to integrate the existing CAPA/OOS system into the QMS
• Interfacing between the site’s quality unit and the global QA department.
Requirements:
• Quality Assurance / Quality Control background with in biopharmaceutical production environment
• Experience working with an aseptic or sterile environment.
• Experience of pharmaceutical Quality Management Systems remediation.
• Good knowledge of GMP/FDA regulations and documentation practices.
• Fluent French language skills.
Should you be interested in this opportunity, please send your up to date CV and cover letter to