Responsible Person Dir Quality Assurance (m/f/d)

microsatsystems.biz

Schachen, Switzerland
Biologics drug substance manufacturing
Clinical supply packaging and distribution
Swissmedic technical interpretation (i-smi.ti.17)
The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility that enables and advances our best work

Job Summary

  • The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility that enables and advances our best work.
  • The Site RP (Responsible Person) is a key member of the Quality Leadership Team, having responsibility to ensure that the site meets the expectations as laid out in the Swissmedic Technical Interpretation (I-SMI.TI.17).
  • Utilise this network to help resolve comments and issues that arise during audit and review.

Matching Summary

The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility that enables and advances our best work.

Skills & Requirements

Must-have

  • Biologics drug substance manufacturing
  • Clinical supply packaging and distribution
  • Swissmedic Technical Interpretation (I-SMI.TI.17)
  • Batch release and disposition
  • Deviation and OOS investigations
  • Internal audit program oversight

Nice-to-have

  • Cross-functional teamwork and collaboration
  • Mentoring and coaching auditors
  • Continuous improvement initiatives
  • Permanent inspection readiness

Key Requirements

  • Bachelor’s degree or higher in Life Science
  • 10+ Years in Quality Role
  • Eligible as Responsible Person per I-SMI.TI.17
  • Experience with Quality enterprise systems
  • Experience supporting regulatory inspections (Swissmedic)

Work Rights

Not specified

Tailored Resume

Cover Letter