(sr.) Specialist, Ls & Asat, Biologics

Roche

Shanghai, China
Qc experience with bioanalytical testing
Equipment qualification and validation
Gmp compliance and cgmp adherence
Roche is hiring for a greenfield facility in Shanghai to manage equipment qualification, validation, and sample management

Job Summary

  • Roche is hiring for a greenfield facility in Shanghai to manage equipment qualification, validation, and sample management.
  • The role requires strong expertise in both greenfield project execution and routine operation management under GMP standards.
  • Candidates must ensure compliance with global/local procedures, cGMP requirements, and CN/EU Annex-1 regulations.

Matching Summary

Roche is hiring for a greenfield facility in Shanghai to manage equipment qualification, validation, and sample management.

Skills & Requirements

Must-have

  • QC experience with bioanalytical testing
  • Equipment qualification and validation
  • GMP compliance and cGMP adherence
  • Sample and material management
  • CN/EU Annex-1 regulatory knowledge

Nice-to-have

  • Project management skills preferred
  • MNC Bio-pharma experience preferred
  • Lean initiatives in lab operations
  • Fluent English communication skills
  • Digital system deployment support

Key Requirements

  • Bachelor's Degree in Life Sciences or related field
  • 2+ years of QC experience in bioanalytical testing
  • Experience with aseptic assurance and physical/chemical testing

Work Rights

Not specified

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