Sofie Vercammen Email and Phone Number
Sofie Vercammen is a Registration Officer and label responsible at Certiplant. She possess expertise in pharmaceutical industry, validation, regulatory affairs, quality assurance, fda and 20 more skills. She is proficient in English.
Certiplant
View- Website:
- certiplant.be
- Employees:
- 4
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Registration Officer And Label ResponsibleCertiplantFlanders, Belgium -
Registration Officer/Label ResponsibleCertiplant Sep 2016 - Present -
Senior Qa OfficerToxikon Europe Jan 2016 - Sep 2016Haasrode- QC/QA review of data- Follow-up of deviations, investigations, CAPA, complaints, change controls, OOS- Assess and monitor systematically the extent in which quality standards and procedures are met (Ph.Eur., JP, USP, Eudralex, FDA and ICH)- Perform and follow-up of Internal audits- Preparation and follow-up of the Contract giver audits- Preparation and follow-up of the regulatory authorities audits (FDA; FAGG; BELAC,…)- Quality assurance manager assistant- Management of specially regulated substances (Import/Export, stockmanagement, wastemanagement)
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Qa AssistantToxikon Europe Apr 2013 - Jan 2016Haasrode, Belgium- QC/QA review of data- Follow-up of deviations, investigations, CAPA, complaints, change controls, OOS- Assess and monitor systematically the extent in which quality standards and procedures are met (Ph.Eur., JP, USP, Eudralex, FDA and ICH)- Perform and follow-up of Internal audits- Preparation and follow-up of the Contract giver audits- Preparation and follow-up of the regulatory authorities audits (FDA; FAGG; BELAC,…)- Quality assurance manager assistant
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Qa AssistentQplus Consult Bvba Nov 2012 - Apr 2013Boutersem, Belgium- Assess and monitor systematically the extent in which quality standards and procedures are met (Ph.Eur., JP, USP, Eudralex, FDA, ICH, GDP)- Quality Review Document (QRD)- Regulatory affairs: * Control and correction of Packagematerial of pharmaceutical products * Control and correction of Patient information leaflets * Organizing and checking of translations of the leaflets (NL, FR, DE) * Preparation of electronic submissions in accordance with the latest guidelines (eCTD) -
Qa-SpecialistLanden Pharmachem Jul 2011 - Oct 2012Landen, Belgium- Annual product review- Review of Batch andTechnical documents- Follow-up of deviations, investigations, CAPA, OOS and OOT- Assess and monitor systematically the extent in which quality standards and procedures are met (Ph.Eur., JP, USP, Eudralex, FDA and ICH)- Perform and follow-up of Internal audits- Preparation and follow-up of costumer audits- Preparation and follow-up of regulatory authorities audits (FDA; FAGG)- Quality assurance manager assistant- QC/QA release of test-samples, raw materials and final products
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Qc-SpecialistLanden Pharmachem Nv Aug 2010 - Jul 2011Landen- QC Review of Data- Follow-up of OOS and OOT- Assess and monitor systematically the extent in which quality standards and procedures are met (Ph.Eur., JP, USP, Eudralex, FDA and ICH)- Follow-up of the qualification of the labequipment - Preparation and follow-up of company audits- Preparation and follow-up of regulatoryauthorities audits (FDA; FAGG)- Stock management
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Process AssistentImec Aug 2006 - May 2009Heverlee, Belgium- Batch-tracking- Lab responsible- Safety inspections- Sample preparation- Scanning electron microscopy- Working in a cleanroom environment
Sofie Vercammen Skills
Sofie Vercammen Education Details
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KhleuvenPharmaceutical Assistant -
KhlimB -
KcstSciences-Mathematics
Frequently Asked Questions about Sofie Vercammen
What company does Sofie Vercammen work for?
Sofie Vercammen works for Certiplant
What is Sofie Vercammen's role at the current company?
Sofie Vercammen's current role is Registration Officer and label responsible.
What schools did Sofie Vercammen attend?
Sofie Vercammen attended Khleuven, Khlim, Kcst.
What skills is Sofie Vercammen known for?
Sofie Vercammen has skills like Pharmaceutical Industry, Validation, Regulatory Affairs, Quality Assurance, Fda, Quality Control, Corrective And Preventive Action, U.s. Food And Drug Administration, Microsoft Office, Microsoft Excel, Project Management, Strategic Planning.
Who are Sofie Vercammen's colleagues?
Sofie Vercammen's colleagues are Hilde Grosemans, Rafaela Dos Reis.
Not the Sofie Vercammen you were looking for?
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Sofie Vercammen
Dvm, Phd Researcher At Faculty Of Veterinary Medicine - Ghent UniversityLouvain Metropolitan Area -
Sofie Vercammen
Belgium
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