Robbert Van Berkel Email and Phone Number
Robbert Van Berkel personal email
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Robbert Van Berkel is a Senior Quality Assurance and Regulatory Affairs at Intracare B.V.. He possess expertise in product development, regulatory affairs, medical devices, biomedical engineering, r&d and 5 more skills.
Intracare B.V.
View- Website:
- intracare.nl
- Employees:
- 58
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Senior Quality Assurance And Regulatory AffairsIntracare B.V.Eindhoven, Nb, Nl -
Senior Quality Assurance & Regulatory AffairsIntracare B.V. Jan 2019 - PresentVeghel, Noord-Brabant, NlActivities / achievements:- Responsible for routine QA/GMP tasks (deviations, CAPAs, supplier approval, etc).- Responsible for QA documentation (PQRs, stability studies, change control, etc).- BPR product registrations for biocides in PT2,3,4,5 in the EU.- Registration of vet. medicinal products in the EU by MRP (new API, non-generic).- Study coordinator of (eco)toxicity- and efficacy testing for registration dossiers (in vitro, in vivo). -
Quality Assurance & Regulatory AffairsIntracare B.V. Jan 2015 - Dec 2018Veghel, Noord-Brabant, NlActivities / achievements:- Setting up a complete GMP quality system to obtain a production license for vet. medicinal products. So designing and writing all related SOPs, procedures, records, validations, risk assessments, … , and conducting related training of personnel.- Handling for QA/GMP tasks (PQRs, Stability studies, validations, etc).- Processing routine OOS, deviations, CAPAs, etc.- Responsible for Pharmacovigilance (Notifications, PSURs, DDPS, etc)- Registration of biocidal products in PT2,3,4,5 in the EU (incl BPR).- Registration of vet. medicinal products in the EU by MRP (new API, non-generic).- Renewal to registered veterinary medicinal products. -
Product Development & Regulatory AffairsIntracare B.V. Dec 2010 - Jan 2015Veghel, Noord-Brabant, NlActivities / achievements:- Development of new cleaning/disinfection products and vet. medicinal products.- Developing, validating and implementing new analytical methods for the QC lab.- Developing, validating and implementing new product manufacturing processes.- Registration of biocidal products for use in PT2,3,4 in the EU (not BPR).- Registration of vet. medicinal products in the EU (new API, non-generic).- Variations to registered veterinary medicinal products.- Management of labels, SPCs, MSDSs and other product literature. -
Manufacturing Support OfficerEuropean Medical Contract Manufacturing Jan 2010 - Dec 2010Nijmegen, NlActivities / achievements:- development of different types of bone graft substitutes derived from processed donor bone (demineralised bone, cortical bone, trabecular bone, possibly supplemented with antibiotics, growth factors, etc) - development of the preparation of collagen fleeces by processing porcine pericardia -
Graduation ProjectMaastricht University Jan 2009 - Oct 2009Maastricht, Limburg, NlDevelopment of radiopaque polymeric microspheres, supplemented with doxorubicin, for the treatment of hepatocellular carcinoma. -
InternshipTno Sep 2008 - Dec 20082595 Da The Hague, NlDevelopment of thermo-induced water-based hydrogels as invertebral disc replacement.
Robbert Van Berkel Skills
Robbert Van Berkel Education Details
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Eindhoven University Of TechnologyBiomedical Engineering -
Eindhoven University Of TechnologyBiomedische Technologie
Frequently Asked Questions about Robbert Van Berkel
What company does Robbert Van Berkel work for?
Robbert Van Berkel works for Intracare B.v.
What is Robbert Van Berkel's role at the current company?
Robbert Van Berkel's current role is Senior Quality Assurance and Regulatory Affairs.
What is Robbert Van Berkel's email address?
Robbert Van Berkel's email address is ro****@****ail.com
What schools did Robbert Van Berkel attend?
Robbert Van Berkel attended Eindhoven University Of Technology, Eindhoven University Of Technology.
What are some of Robbert Van Berkel's interests?
Robbert Van Berkel has interest in Video Editing, Basketball.
What skills is Robbert Van Berkel known for?
Robbert Van Berkel has skills like Product Development, Regulatory Affairs, Medical Devices, Biomedical Engineering, R&d, Biotechnology, Gmp, Research, Pharmaceutical Industry, Quality System.
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