Experience

Linde Gas Therapeutics Benelux B.V.

• Netherlands
• Chemical Manufacturing
• 1 - 100 Employee

• Qualified Person / Responsible Person

  • May 2018 - Present



Beschikbaar voor werk

• Eindhoven en omgeving, Nederland

• Beschikbaar voor werk

  • Jun 2017 - May 2018



Dechra Pharmaceuticals

• Bladel

• Scientist Pharmaceutical Development

  • Jun 2015 - Jun 2017

  Dechra Bladel, formerly known as Eurovet Animal Health BV Work included: - Writing Part 2 (European equivalent of the CMC section) for European submissions (and similar submissions for outside Europe). - Maintenance of current registrations (variations) - Assessing of newly received Active Subtance Master Files (ASMF / DMF) - Conducting and accompanyning of internal GMP audit in association with QA (Qualified Person) - Keep record of performed external GMP audits (and keeping record of the audit planning to maintain current registrations). Extensive experience with ICH / GMP guidelines. Show less



Aspen Pharma Australia

• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Senior Investigator

  • Apr 2013 - May 2015

  To assess and interpret stability studies in a GMP environment. Work included: - Initiation and coordination of stability studies of all on-site manufactured API’s. - Evaluate and when necessary coordinate root-cause investigation of Out Of Specification (OOS) results using a Trackwise based system. - Produce annual reports of all on-site manufactured API’s. - Optimize (complex) business processes using Lean Six Sigma / TPS philosophy. Extensive experience with ICH / GMP guidelines. Show less



Eurofins Central Laboratory

• United States
• Biotechnology Research
• 200 - 300 Employee

• Study Director

  • Jul 2008 - Apr 2013

  Coordinate and direct studies in the Biomarkers and Biopharmaceuticals Department. Prepare study plans for assay validation and routine analysis, coordinate the execution of the studies and report the results to the customer.Work included:- The coordination of GLP compliant studies conducted on the Bioanalytical and the Biomarkers & Biopharmaceutical department.- Setting up study protocols for (pre)validation studies and routine analysis, including managing and running these studies.- Maintaining contact with all parties involved such as R&D, Regulatory Affairs, Intellectual Property, Quality Assurance etc.- Interpretation and evaluation of generated results.- Implemented methods include ELISA, ECLIA, Flow cytometric assays, enzymatic assays, HLPC, GC-MS, LC-MS/MSExtensive experience with OECD-GLP guidelines. Show less

• Chemical Analist

  • Sep 2005 - Jun 2008

  Performing analytical work in the bioanalytical department, with emphasis on biomarker studies. Work included assay validation, routine analysis software and hardware validation under GLP conditions.



Dixons

• sales representative

  • 2001 - 2005