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.
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.