Post Market Surveillance Analyst

• Jul 2017 - Present

Quality Assurance Team Leader

• Mar 2017 - Jul 2017

Senior Outsourced Operations Quality Assurance Officer

• Jul 2015 - Mar 2017

Supplier Management of Medical Device Manufacturers- Audit- Approval- Change Control- Deviations- Product release

External Manufacturing Quality Leader

• Jun 2012 - Jun 2015

Ensure Supplier and Contractor activities are fully compliant with regulatory and RB guidelines to minimise risk to consumers, company and brand name.The approval (or rejection) of new suppliers and contractors.UK and international travel to audit or visit suppliers or contractors.Recommend suspension of supply on the basis of failures in Supplier quality management systems. Ensure Supplier and Contractor activities are fully compliant with regulatory and RB guidelines to minimise risk to consumers, company and brand name.The approval (or rejection) of new suppliers and contractors.UK and international travel to audit or visit suppliers or contractors.Recommend suspension of supply on the basis of failures in Supplier quality management systems.

QA Specialist - Compliance & Team Leader - TrackWise

• Oct 2010 - Jun 2012

In charge of supplier auditing at Haverhill.Team Leader of the TrackWise admins.TrackWise SME at Haverhill for CAPA and Inernal Audits.Assisting with Internal audits as a Lead Auditor.Global subject matter expert in Genzyme on Internal auditing and Supplier auditing.Assisting in the creation and maintenance of Quality Management System elements.

Senior QA Officer - Audit Management

• May 2009 - Oct 2010

Working in the newly formed Quality Compliance Systems Support group, I am responsible for managing both Internal (self inspections) and External (Supplier/Vendor) audit systems within the Haverhill site as well as helping with the construction of the new Quality Management System.

Senior QA Officer - Primary Operations

• Apr 2007 - May 2009

Supervisor in charge of 2 QA OfficersMain duties include release of non GMP batches, review of GMP API batches, performance of internal audits, performance of supplier audits, maintenance of spreasheet qualification system, maintenance of CAPA & deviation system

QA Officer - Primary Operations

• Feb 2002 - Apr 2007

Review of all batches (GMP and non GMP)performance of Internal AuditsFollow up on all CAPA and Deviations

Auditor 1

• Oct 1999 - Feb 2002

GMP review of Clinical Trial Stability DataGMP review of Clinical Trial Batch Records GMP review of Clinical Trial Stability DataGMP review of Clinical Trial Batch Records