Experience

• 

  Pfizer

  Jan 1993 - May 2012

  • Team Leader

    Sept 2009 - May 2012

  • Laboratory Team Leader

    Jan 1993 - Aug 2009
• 

  Novartis / gsk

  Jun 2012 - Feb 2016

  Analytical services manager
• 

  Gsk

  Apr 2017 - Mar 2018

  Qc manager
• 

  Avara pharmaceutical services

  Apr 2018 - Nov 2019

  Qc manager
• 

  Quality executive partners, inc. (qxp)

  Jan 2019 - Jul 2021

  Independent consultant

  Laboratory OversightData ReviewOOXs and Deviations - Evaluation / CoachingSupport to Remediation Activities

• 

  Quality by design consulting

  Aug 2021 - Nov 2021

  Consultant

  Responsible to oversee and ensure GMP compliance in Quality and Manufacturing operations.Support in the preparation and writing of OOSs investigations.Guidance and coaching for applicable and required investigational tools, methods and report writing in scope of the project, as per client needs.

• 

  Validant

  Oct 2021 - Jan 2022

  Independent consultant

  Provide professional services and expertise to establish and improve quality system activities and procedures in gene therapy.Perform quality control document reviews of method validation and stability documents on behalf of Client’s QA division.Review of the GMP and GDP in equipment validation protocols and reports.

• 

  Carlton national resources

  Feb 2022 - May 2022

  Independent consultant

  Batch Record Review.QC gene therapy Data Review.OOXs and Deviations - Evaluation / Coaching

• 

  Validant

  Jun 2022 - Dec 2022

  Independent consultant

  Quality OversightSupport and facilitate the overall OOS (Phase I and Phase II)Manage staff on the shop floor to ensure products meet specifications and regulations are followed for Client products.