Steven Graham

Integrated Commissioning & Qualification, Corp. | Validation Consultant

About Me

Manufacturing professional in the pharmaceutical industry with experience in Six Sigma concepts to increase productivity, cGMP and regulatory guidelines, MRC-5 cell line management, Steam/ Dry Heat Sterilization, handling regulatory inspections, instrument quality control; advanced user of SAP supply chain management; skilled in people management, and Lean Six Sigma problem identification and resolution.

Work Experience

Integrated Commissioning & Qualification, Corp.
Validation Consultant
August, 2014
  • Consultant II

  • Shire (5/2014 Present)

  • Primary responsibilities: Manufacturing System Lifecycle (MSL) document remediation.

  • Created qualification standards in accordance with Shire MSL practices.

  • Created a transition plan to bring Latin American manufacturing sites in line with current MSL standards.

  • Document revision and comment remediation.

  • Developed Validation Master Plans for the tracking of validation compliance within Shire manufacturing locations.

  • Takada (6/2014- 5/2015)

  • Primary responsibilities: Writing and editing Global Standards for an internationally based Pharmaceutical client.

  • Harmonized international guidelines from 9 different pharmaceutical governing bodies into over 70 standards.

  • Used Excel to trace each standard back to a guideline, ensuring that all international guidelines will be followed by the client.