M&s-qa Ops Manager & Pcu Manager-beijing

Sanofi

Beijing, China
Cgmp legal and regulatory requirements
Batch record review and release
Deviation and capa handling
Act as the QA PCU Lead to respond to operational QA business for PCU, providing quality assurance oversight by performing routine walk-throughs and inspections

Job Summary

  • Act as the QA PCU Lead to respond to operational QA business for PCU, providing quality assurance oversight by performing routine walk-throughs and inspections.
  • Manage the PCU deviation and related customer complaint, corrective and preventative actions (CAPA), out of specification (OOS) handling, and monitor CAPAs.
  • Develop people via training and coaching to enable them qualified for QA PCU work and perform people performance management.

Matching Summary

Act as the QA PCU Lead to respond to operational QA business for PCU, providing quality assurance oversight by performing routine walk-throughs and inspections.

Skills & Requirements

Must-have

  • cGMP legal and regulatory requirements
  • batch record review and release
  • deviation and CAPA handling
  • quality oversight and GMP documentation
  • supplier inspection participation
  • HSE requirements implementation

Nice-to-have

  • continuous improvement mindset
  • energy saving awareness
  • people development via training
  • cross-functional investigation support

Key Requirements

  • minimum 10 years experience in quality
  • 3 years in management position
  • Bachelor degree in pharmacy or chemistry
  • Good English verbal & written communications

Work Rights

Not specified

Tailored Resume

Cover Letter