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

Imsapharma Com Ar

Schachen, Switzerland
Responsible person for batch release
Swissmedic technical interpretation compliance
Batch record reviews and certification
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).
  • Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.

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

  • Responsible Person for batch release
  • Swissmedic Technical Interpretation compliance
  • Batch Record reviews and certification
  • Deviation and OOS investigations
  • Internal audit program oversight
  • Health Authority notifications

Nice-to-have

  • Cross-functional teamwork and collaboration
  • Continuous improvement initiatives
  • Permanent Inspection Readiness
  • Client relationship building
  • Mentoring staff

Key Requirements

  • Bachelor’s degree in Life Science
  • 10 Years + Experience in Quality Role
  • Eligible as Responsible Person per I-SMI.TI.17
  • Experience supporting regulatory inspections
  • Strong project management skills

Work Rights

Not specified

Tailored Resume

Cover Letter