Qc Analytical Methods Lifecycle Lead

GSK

Analytical methods lifecycle management
Difficult analytical investigations
Quality oversight for npi
This role consists in supporting difficult analytical investigation, LICs and PIRCs, review analytical submissions source documents and support to audits

Job Summary

  • This role consists in supporting difficult analytical investigation, LICs and PIRCs, review analytical submissions source documents and support to audits.
  • Provide SME support to methods lifecycle issues collaborating with all the functions involved in analytical space.
  • These responsibilities include some of the following: Provide SME support for analytical transfer, methods troubleshooting, specs settings and analytical methods definition, submission files.

Matching Summary

This role consists in supporting difficult analytical investigation, LICs and PIRCs, review analytical submissions source documents and support to audits.

Skills & Requirements

Must-have

  • analytical methods lifecycle management
  • difficult analytical investigations
  • quality oversight for NPI
  • GMP knowledge
  • FDA/EU/ICH regulations

Nice-to-have

  • technical knowledge for DMAIC
  • ambitious for patients
  • accountable for impact
  • doing the right thing

Key Requirements

  • Masters degree in relevant science
  • 5+ years in Quality function
  • Quality control experience

Work Rights

Not specified

Tailored Resume

Cover Letter