Experience

Zoetis Belgium SA

• Belgium
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• ESQA Senior Manager EUAfME

  • Nov 2020 - Present

  Zaventem, Flemish Region, Belgium ESQA EUAfME Senior Manager



Zoetis

• ESQA EUAfME Manager

  • Jun 2017 - Nov 2020

  Zaventem Nossegem, Flanders, Belgium



Shire

• Japan
• Biotechnology Research
• 700 & Above Employee

• QA Lead GMP and Clinical Operations

  • Apr 2016 - May 2017

  Brussels Area, Belgium Batch disposition group for ex ViroPharma products and Clinical ops QA lead for a Shire product phase 3 IMP



ViroPharma Incorporated ;-)

• Snr QA Associate Europe

  • Aug 2012 - May 2016

  Brussels Area, Belgium Provide QA oversight as a single point of contact for two CMO manufacturers, both based in Sweden. Also backing up of the single point of contact for two CMO's, (one in Belgium, the other in the Netherlands). QA Oversight involves QA advice for the scaling up and development of the product assigned to me (validation), routine batch review, deviations, CAPA management, Change management, Artwork approvals, auditing and regular technical meetings.



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QA Primary Support Manager

  • Aug 2011 - Jul 2012

  Rixensart / Wavre Belgium Provide QA Support to the Primary (Bulk) Biologicals business unit in terms of Inspection readiness. Providing advice within the Quality Council and providing formal deviation metrics from SAP extracts.

• Primary Support Manager

  • Aug 2011 - Jul 2012

  Rixensart, Belgium Seconded to Belgium as Primary Support Manager. Ensuring Regulatory Inspection Readiness, and timeliness of responses, preparing Quarterly deviation reports and coaching in deviation and CAPA handling. (Secondment)

• External Supply Quality Contact

  • Nov 2010 - Jul 2011

  Crawley, UK Secindment to GSK External Supply providing GSK QA oversight for contract manufacturer based in Slough UK for a biological product. Working remotely as a "Person in Plant" within the CMO to ensure that GSK (as the MA holder) had a vital product manufactured to GSK standards. Was single point of contact (QA) between CMO and GSK

• Assistant Quality Manager

  • Jan 2004 - Oct 2010

  Crawley, UK Provide QA oversight on various solid dose business units within the site, as well as QC testing. Japan complaints co-ordinator.

• Quality Assurance Compliance Officer

  • Jan 1998 - Jan 2004

  Provided QA Oversight for various production units throughout the site, including Syrups, ablets, capsules and sachets. Was responsible for sentencing incoming API to the site from external supplier



SmithKline Beecham Worthing

• Syrup Packaging Technician

  • Jan 1996 - Jan 1998