Robbert Van Berkel

Robbert Van Berkel Email and Phone Number

Senior Quality Assurance and Regulatory Affairs @ Intracare B.V.
Eindhoven, NB, NL
Robbert Van Berkel's Location
Eindhoven, North Brabant, Netherlands, Netherlands
Robbert Van Berkel's Contact Details

Robbert Van Berkel personal email

About Robbert Van Berkel

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.

Robbert Van Berkel's Current Company Details
Intracare B.V.

Intracare B.V.

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Senior Quality Assurance and Regulatory Affairs
Eindhoven, NB, NL
Website:
intracare.nl
Employees:
58
Robbert Van Berkel Work Experience Details
  • Intracare B.V.
    Senior Quality Assurance And Regulatory Affairs
    Intracare B.V.
    Eindhoven, Nb, Nl
  • Intracare B.V.
    Senior Quality Assurance & Regulatory Affairs
    Intracare B.V. Jan 2019 - Present
    Veghel, Noord-Brabant, Nl
    Activities / 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).
  • Intracare B.V.
    Quality Assurance & Regulatory Affairs
    Intracare B.V. Jan 2015 - Dec 2018
    Veghel, Noord-Brabant, Nl
    Activities / 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.
  • Intracare B.V.
    Product Development & Regulatory Affairs
    Intracare B.V. Dec 2010 - Jan 2015
    Veghel, Noord-Brabant, Nl
    Activities / 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.
  • European Medical Contract Manufacturing
    Manufacturing Support Officer
    European Medical Contract Manufacturing Jan 2010 - Dec 2010
    Nijmegen, Nl
    Activities / 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
  • Maastricht University
    Graduation Project
    Maastricht University Jan 2009 - Oct 2009
    Maastricht, Limburg, Nl
    Development of radiopaque polymeric microspheres, supplemented with doxorubicin, for the treatment of hepatocellular carcinoma.
  • Tno
    Internship
    Tno Sep 2008 - Dec 2008
    2595 Da The Hague, Nl
    Development of thermo-induced water-based hydrogels as invertebral disc replacement.

Robbert Van Berkel Skills

Product Development Regulatory Affairs Medical Devices Biomedical Engineering R&d Biotechnology Gmp Research Pharmaceutical Industry Quality System

Robbert Van Berkel Education Details

  • Eindhoven University Of Technology
    Eindhoven University Of Technology
    Biomedical Engineering
  • Eindhoven University Of Technology
    Eindhoven University Of Technology
    Biomedische 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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