Senior Manager Quality Assurance/ Qualified Person
Pfizer
مجموع سنوات الخبرة :9 years, 6 أشهر
Product Release (of investigational medicinal products), deviation/change control management, validation/equipment qualification, drafting of standard operating procedures, QP declarations and quality agreements and ensuring compliance with the European (EU-GMP) and US (FDA) regulations.
Qualified Person, key responsibilities include: Performing batch certification and batch release of pharmaceutical raw materials, packaging materials, semi-finished and finished products, ensuring that different effective pharmaceutical quality management systems (documentation, validation, GMP training, deviations incl. complaints Change Control systems and recalls) are operated, ensuring compliance with the conditions of the marketing authorization and interacting with the regulatory department, demonstrating expertise regarding quality assurance (QA), current good manufacturing practices (cGMP) including good distribution practices (GDP) and quality control (QC) in interactions with clients, authorities and other interested parties, writing and implementing QA agreements with suppliers and subcontractors, applying high ethical standards and professional conduct with clients and authorities
Apr 2013- Present Apotex Nederland B.V., Leiden
Qualified Person, key responsibilities include: Performing batch certification and batch release of pharmaceutical raw materials, packaging materials, semi-finished and finished products, ensuring that different effective pharmaceutical quality management systems (documentation, validation, GMP training, deviations incl. complaints Change Control systems and recalls) are operated, ensuring compliance with the conditions of the marketing authorization and interacting with the regulatory department, demonstrating expertise regarding quality assurance (QA), current good manufacturing practices (cGMP) including good distribution practices (GDP) and quality control (QC) in interactions with clients, authorities and other interested parties, writing and implementing QA agreements with suppliers and subcontractors, applying high ethical standards and professional conduct with clients and authorities
Jun 2012- Apr 2013 Duchefa Farma B.V., Haarlem
• Pharmacist (QA/QC), main responsibilities within the quality department on a daily basis are the ultimate release of pharmaceutical raw materials into the market, supplier qualification, authorizing certificates of analysis and material safety data sheets, providing guidance and training to a team of (four) quality officers, providing supervision in the absence of the quality manager, maintaining the deviation/CAPA management system, serving as a first point of call for GMP and ISO 9000 related questions, coordinating and carrying out internal audits and monitoring the collaboration of the various departments on a QA level.
In addition, several other tasks like maintaining the quality management system (Change Control), settling of internal and external complaints and drawing up and maintaining quality criteria for primary and secondary packaging materials are carried out on a regular basis.
2008-2011 CV Heezik, Utrecht
• Administrative assistant: administrative and office support activities for multiple supervisors. Duties include fielding telephone calls, receiving and directing visitors, word processing, filing, and faxing. Extensive software skills are required, as well as Internet research abilities and strong communication skills.
Apr-Jun 2011 Zuwe Hofpoort Ziekenhuis, Woerden
Hospital pharmacy internship
Achieved a number of objectives concerning both medication and patient related problems. Aspects concerning the handling, preparation, storage, distribution, pricing and quality of drugs were covered. Furthermore different patient oriented matters like treatment, counseling, coaching, informing were covered.
Jan-Mar 2011 Community pharmacy internship (prolonged)
In addition to the objectives mentioned above, a number of assignments was carried out covering different subjects: e.g. poly pharmacy, preference policy of generic drugs, human resources and strategic planning (SWOT analysis)
Nov-Dec 2010 Boots apotheek Ziekenzorg, Utrecht
Apr-Dec 2009 Merck & Co., Inc., Oss Research internship Title of the research report: the characterization of a biological and optimization of its formulation. The project took six months during which I had to write a scientific research report. Within the study pharmacy this is regarded as the alternative for a master thesis. Grade: 9 out of 10
2007-2008 Apotheek Dorestede (community pharmacy), Wijk bij Duurstede
• Student assistant during the summer periods on a full time basis.
2006-2008 Direct Dial, Call center, Utrecht
• Outbound, business to business sales representative.
• Delivered prepared sales scripts to persuade potential customers (small and medium-sized
businesses) to purchase energy contracts from a major power company.
• Responded to customer questions and obtained possible customer leads.
• Followed up on initial contacts.
INTERNSHIPS
2000-2003 Pre-University education, d'Oultremontcollege, Drunen