1. Quality management system
• Responsible to make proposals to the Medical Director, related to development of procedures, SOPs, quality management tools, and databases. This responsibility has the international territory of EMEA.
• Responsible for the maintenance of the quality management system based on both internal and external changes in the regulatory and organizational environment.
• Responsible for the training and implementation of the quality management system, including registration and documentation.
• Responsible for the documentation and archiving of all activities related to the quality management system.
2. Compliance
• Conducts audits both within and with the business partners, in order to ensure compliance to the quality management system.
• Advises pro-actively (unsolicited) and reactively (solicited) on quality issues, throughout the organization and where required to licensees and agents.
• Advises on product recalls to the management team
• The scope of the compliance responsibility can be extended to business partners.
• Represents the company in product recall teams when applicable.
• Responsible for signalling divergences of the compliance rules to the Medical Director and/or management team, on technical agreements, safety contracts, etc. themselves, or to required follow-up of these agreements or contracts.
3. Drug safety data
• To ensure there are appropriate pharmacovigilance systems in place in the affiliate to ensure compliance with EU policies and local laws and guidance
• To ensure that there are appropriate pharmacovigilance systems in place in the external business partners.
• To ensure the legal basis for the exchange of safety data with the business partners.
• To check for adverse events in the complaint handling procedure. |
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• Preferably 3-4 years experience with international regulatory affairs or QA-activities in the pharmaceutical industry
• Experience in working in multidisciplinary teams
• Experience in working in matrix organizations.
• Experience in monitoring, defending and executing on quality standards within a pharmaceutical company.
• Academic qualifications preferably as a pharmacist, chemist or (medical) biologist
• Ability to work in a well organized project management, result oriented way also under pressure
• Excellent communication and writing skills (advise, convince, negotiate, listen, coach, present and edit)
• Relatively high abstraction level, to be able to switch to required levels and stand-points
• Ability to generate a realistic work-planning, derived from a vast number of data and information
• Good contactual skills (positive & constructive attitude, desire and ability to work in multidisciplinary / international teams)
• Good knowledge of the internal and external regulations which are applicable
• Adequate knowledge to work with information technology systems (e.g. Windows, MS Office and Dbases)
• Fluent in English language, both spoken and written
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