Senior Quality System Manager

vor 1 Woche

Wallis, Schweiz Talentor Switzerland Vollzeit

Start date: ASAP


End date: 06/09/2024



Responsibilities:



  • Provide immediate support to operations and quality control staff to address compliance related concerns.
  • Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
  • Audit internal quality system elements in manufacturing and operational support areas. Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations. Perform external audits of suppliers/vendors/off-site facilities.
  • Act as a customer interface during on-site audits, conference calls and other standard means of communication.
  • Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
  • Prioritize and manage a variety of projects simultaneously. May need to lead and direct the work of others.
  • Review and approve validation documents. Review and Master Batch Records (MBR) and supporting documents.
  • Perform review/release of batch records, as needed. Key requirements: Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.


Requirments:



  • 5 years of relavant experience in pharmaceutical industry.
  • Experience in GMP compliance and Part 11.
  • Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
  • Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast paced environment; team oriented; independent work skills and a strong work ethic.

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