Experience

AGC Biologics Management Consulting

QA Manufacturing Consultant

11/2020 - Present

Support AGC Biologics on investigation, Root Cause Analysis, CAPAs, manufacturing and release of protein therapeutic bulk drug substances

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Avalo Therapeutics Management Consulting

QA Consultant

5/2021 - Present

Responsible for ensuring product manufacture and supply meet the established standards of Quality and adherence to the Quality Management System (QMS) across Avalo's network of vendors ad internal business partners.

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Tolmar Management Consulting

QA Consultant

6/2020 - 1/2022

Provide coaching and mentorship to Tolmar colleagues on their CAPAs, Investigations and Root Cause Analysis as part of an FDA 483 Regulatory commitment.

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Sanofi Management Consulting

QA SAP Consultant

7/2021 - 10/2021

Support Sanofi Toronto site on the Implementation and validation of SAP 4HANA ERP system as a Quality Key User.

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Inovio Pharmaceuticals Management Consulting

Sr. QA Compliance Consultant

2/2021 - 4/2021

Support the reduction of NCS / CAPAs through a triage approach and maintain control over new NCRs that arise during normal production.

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The Cronos Group Management Consulting

CQV Consultant - Engineering & Automation

9/2020 - 12/2020

Write and execute the IOQ protocols for Engineering & Automation for the equipment and process line.

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Pfizer Management Consulting

Quality Investigator - Consultant

7/2018 - 5/2020

Assist the largest pharma manufacturer of sterile injectable controlled substances in USA on their FDA remediation project in McPherson Kansas.

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Therapure Biopharma Management Consulting

Deviation Specialist

11/2017 - 7/2018

Lead Investigator and Technical writer for the Aseptic manufacturing unit.

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Baxter Pharmaceuticals Management Consulting

GMP Specialist

5/2016 - 11/2017

Support Medical Device compounding site for Quality, Compliance and Validation activates.