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Summary

I love dynamic environments. I am known for being a team player, dutiful and punctual. Organizing and coordinating is my passion: respect for deadlines without losing sight of the quality of the work. I think together with the customer and analyze their problem. I enjoy learning and exploring new aspects in my day-to-day job. As a consultant, I am always ready to challenge myself in a new role.

Experiences

Current Experience

  • Managing Director - Pharmaceutical consultant
    Since January 2015
    Consult10 bvba offers Quality and Regulatory services in de pharmaceutical and healthcare industry. Thanks to a broad network, other services can be offered as well. Tine has more than 7 years of experience as consultant in pharmaceuticals and health sciences. Her expertise includes Quality Assurance, Regulatory Affairs and Advertising & Promotion. She has played a key role in the success of many national and international projects for big pharma companies. Specialties: - Advice on strategy of Benelux and European company-constructions from pharmaceutical legislation point of view, - Application file submissions for distribution and import licenses: the entire package, including QATAdiscussions, SOP writing, QA system implementation and maintenance, preparation and guidance of inspections, in-company trainigs and audits - Daily routine QA work: admin release, complaint handling, CAPA management, recall, etc - Advertising & Promotion in OTC, medical device and cosmetic environment including in-company training - Regulatory Affairs in pharmaceutical, food, medical device and cosmetic environment

Past Experience

  • Senior Pharmaceutical Consultant Leuven, België
    January 2012 --- December 2014
    As an experienced QA consultant, I optimize and manage the entire QA system for companies and products entering the Benelux and European market. Specifically regarding QA system implementation (national and international), I set up and write standard operating procedures. Afterwards, I am responsible to give trainings and support during the implementation. I execute regular internal audits to check the effectiveness of the implementation and to improve the processes. I am seasoned in the execution of daily processes as well, which includes administrative release, complaint handling, CAPA management, and more. In a number of big pharma companies, I successfully completed several QA-related projects such as international moves of distribution centers, company mergers, GMP compliant set up of importation constructions in the EU, including application file submissions for distribution and import licenses. I have prepared and guided several Health Authority inspections and internal audits by internal Global and European Quality organizations and managed the action points. Regulatory Affairs As a regulatory affairs officer, I perform submissions of marketing authorization applications and variations on a day-to-day basis. I have acquired expertise in the submission process of medicinal products (MRP, DCP and national procedures), cosmetics and food. To my customers, I am the liaison with regulatory authorities and I maintain close interaction with the international regulatory organization. Direct interaction with the marketing departments is essential, including submission of Marketing based variations, coping with very stringent deadlines. Next to these tasks, I implement the approved variations. As a regulatory consultant, I provide regulatory advice on applicable national legislations and regulatory procedures and, if necessary, training services for regulatory affairs in the company. Advertising and Promotion

  • Pharmacist consultant
    April 2008 --- December 2011

  • Compliance specialist
    January 2008 --- January 2008

  • apotheker vervanger
    January 2007 --- January 2007

Knowledge

LinkedIn Assessment :
Good Distribution Practice (GDP)Regulatory affairsCAPAPharmaceutical IndustrySOP writingPharmaceuticsGXPRegulatory submissionsGMPLifesciencesRegulatory RequirementsPharmacovigilancePharmacistsChange ControlPharmacypharmacology

Education

  • in Vacature Vlerick Summerschool 6-12 July 2008 from Vlerick Business School in 2008
  • Master of science in Pharmaceutical Sciences from Katholieke Universiteit Leuven in 2005
  • in Latijn-wetenschappen from Het Spijker, Hoogstraten in 2000

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
French
Elementary Proficiency
English
Professional Proficiency

Work Preferences

  • Positions I am interested in:
    QA Consultant Regulatory Affairs Consultant
  • Work From Home:
    No
  • Work Regime:
    BrightOwl freelancer
  • International:
    No

Area / Region

Herent, België

Others

Driving License
  • Yes