Quality Control Consultant - Singapore

Only for registered members Singapore

1 month ago

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Job summary

Lead and execute strategic QC assessments gap analyses remediation projects for biopharmaceutical clients including mAbs recombinant proteins vaccines and advanced therapy medicinal products.


Responsibilities

  • Advise on cGMP compliance with a focus on laboratory practices data integrity ALCOA+ and quality systems.
  • Support clients in preparing for regulatory inspections pre-approval routine and for-cause.
  • Conduct root cause analyses lead investigations for Out-of-Specification OOS Out-of-Trend OOT lab deviations review analytical method validation transfer verification protocols reports assess document management systems SOPs batch records electronic data systems LIMS CDS provide expert input modernization digital transformation operational efficiency initiatives collaborate cross-functional teams deliver client presentations technical reports actionable roadmaps aligned business compliance objectives contribute thought leadership proposal development capability building within AMARIS's Life Sciences practice.< / li>

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