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QC MI&S Specialist ( Pharmaceutical MNC, GMP, Medical)

Company

Recruit Express Pte Ltd.

Location

singapore, Singapore

Type

Full-time

QC MI&S Specialist ( Pharmaceutical MNC, GMP, Medical)

Singapore | Posted: Dec 15, 2025

Responsibilities
  • Support QC Method launch activities with QC and other sites/functions
  • Coordinate QC method documents changes for regulatory submission
  • Author of regulatory submission documents
  • Perform trending for laboratory invalid assays
  • Lead and drive invalid results and trend violation investigations independently
  • Site SME of global procedure for Invalid results which involves conducting local training and communication with global procedure owner
  • Lead method-related investigations for unexpected results independently
  • Support Site SME of global procedure for unexpected results in conducting local training and communication with global procedure owner
  • Prepare control assignment Protocol/Report for controls as required.
  • Support Site SME of global procedure for critical materi...

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