M&s-head Of Quality Assurance Operation Unit (apu) & Sterility-beijing

Sanofi

Beijing, China
On-site
Cgmp compliance
Sterility assurance system
Contamination control strategy
Sanofi is seeking a Head of Quality Assurance Operation Unit (APU) & Sterility for its Beijing location. The role involves ensuring compliance with cGMP standards in pharmaceutical manufacturing and leading a quality assurance team to uphold product quality and regulatory standards

Job Summary

  • Assist site quality head to ensure that product is manufactured and controlled under cGMP condition and marketing authorization, develop quality system to be in alignment with local cGMP, industry standards, regulatory expectations and Sanofi requirements.
  • Play a key role as site microbiology contamination control expert to ensure the manufacturing system and quality control system fulfil the regulatory, quality and technical requirements.
  • Manages the QA team under his/her responsibility with respect to all applicable rules. Perform people performance management.

Matching Summary

Match Score: 85

Sanofi is seeking a Head of Quality Assurance Operation Unit (APU) & Sterility for its Beijing location. The role involves ensuring compliance with cGMP standards in pharmaceutical manufacturing and leading a quality assurance team to uphold product quality and regulatory standards.

Skills & Requirements

Must-have

  • cGMP compliance
  • sterility assurance system
  • contamination control strategy
  • quality system development
  • deviation and OOS management
  • change control evaluation

Nice-to-have

  • people performance management
  • energy saving actions
  • strategic thinking
  • leadership skills

Key Requirements

  • 5+ years' experience in quality control and/or quality assurance
  • 3 years management position
  • 3 years of experience in sterility assurance and microbiological control
  • Bachelor degree in pharmacy or chemistry or biology

Work Rights

Not specified

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