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Quality Control Support – QC Lab Operations

Sanofi · Singapour

Senior 🇬🇧 English
Method validation Equipment qualification Good Manufacturing Practices (GMP) Change control Lab investigations

Job description

About the role

Sanofi is seeking a Quality Control Support professional to join its Evolutive Facility in Tuas, Singapore. The role will ensure robust QC processes, compliance with regulatory standards, and continuous improvement across the manufacturing site.

Key responsibilities

  • Represent QC for processes led by the QMS team at site level.
  • Manage consolidated follow‑up and progress tracking of deviations, lab investigations, change controls and CAPAs, coordinating with QC areas and other functions.
  • Contribute to the development, implementation and maintenance of an effective QC compliance program.
  • Ensure issuance and approval of local QC documentation aligned with the site QMS.
  • Investigate and resolve QC events, issues or discrepancies within the assigned perimeter.
  • Implement remediation actions from findings and CAPAs.
  • Provide support during regulatory inspections and audits.
  • Lead continuous‑improvement initiatives in QC in coordination with the QC excellence team.

Required profile

  • Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life sciences/technology.
  • 5‑8 years of experience in QC lab operations, method validation, equipment qualification, raw material release and quality assurance.
  • Strong knowledge of GMP, FDA, EMA and ICH regulations.
  • Experience managing internal audits and external regulatory inspections.
  • Proven ability to analyse complex compliance issues, identify root causes and develop effective solutions.
  • Excellent verbal and written communication skills.

Required skills

  • Method validation
  • Equipment qualification
  • Raw material release
  • Good Manufacturing Practices (GMP)
  • CAPA management
  • Change control
  • Deviation management
  • Lab investigations
  • Regulatory inspection support (FDA, EMA, ICH)
  • QC documentation preparation and approval

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Published 3 months ago

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Sanofi

Singapour