The Randstad, Netherlands
Experienced Senior Consultant/Freelancer with a demonstrated history of working in pharmaceutical and biotech industry as QA specialist and QP. Skilled in Quality Process Improvement and Quality management. Experience in all QA systems (deviations, change control, suppl.qualification, validation, auditing, etc), in sterile production, pharmaceutical and biological production and management functions. Master of Science (MSc), in Pharmacy (pharmacist) from State University Utrecht, Neth.. Strong problem solver and decision taker.
Projects with following clients: *Graham Packaging, Zoetermeer, NL [interim Head QA] *Abbott, Zwolle, NL [QA improvement project] *AstraZeneca, Destelbergen, BE [Product release, QA Support] *Intervet Schering Plough, Boxmeer [Project management, Sterile validation] *Novartis Pharma, Vilvoorde, BE [Interim Head QA, QA Improvement project] *Janssen Pharmaceutica, Geel, BE [Change Control management, Internal auditing] *Thrombogenics, Leuven, BE [Review validation documentation, new product introduction] *Sandoz GmbH, Kundl, AT [Harmonization project, process validation] *Catalent Pharma Solutions (RP Scherer GmbH), Eberbach, GE [Supplier Qualification Project] *DePuy SYNTHES , Johnson&Johnson, Solothurn, CH [CAPA remediation project] * Merck Biopharma, Darmstadt, GE [FDA readiness project] *MSD Biotech, Oss, NL [QP]
Regulatory Inspection of public and hospital pharmacy and of pharmaceutical industry.
Review of the pharmaceutical part of registration dossiers.
Raw Material and Finished Product control