Benelux Regulatory Affairs & Quality Assurance Specialist (m/f/x)

Job content

• Support Maintenance of the Quality Management System and (re)certification according to ISO 9001 certification
• Development and maintenance of Benelux procedures (SOP’s and work instructions) as needed
• Recognizes and proposes continuous process improvements
• Participate in internal, external, corporate and suppliers’ audits preparation and audits performance and follow-up as needed
• Ensure follow-up non-conformance, CAPA and audits observations/opportunities of improvement
• Ensure SOPs trainings assignation via the e-learning system
• Participate to the QMR preparation
  

• Ensure follow-up complaints process related to product quality within Benelux
• Ensure recalls and FSCA activities tasks are done without due delay
• Ensure Suppliers Quality Agreements are in place, documented and updated
• Ensure internal trainings on Medical Vigilance and product complaints procedure
• Ensure on time preparation of department RAQA monthly KPI’s
• Provides on time internally and to customers RAQA requested information & documentation: such as declarations of conformity, CE certificates and user manuals
• Ensure waste taxe declaration submissions (Val-i-pac, Recupel, Bebat (BE), Stibat (Nl), Reprobel)
  

• the QMS is implemented and maintained
• initial and continuous training programs are implemented and maintained
• product complaints treated effectively
• suppliers are approved
• participate in internal and suppliers audit and ensure documentation and follow-up
• Ensure recalls operations for medicinal products are promptly performed
• Review and ensuring good documentation of batch release reports
• Assist the manager in his/her role of person responsible for pharmacovigilance
• Support in GDP audits by the FAMHP
• Support in submission of variations/renewals for the pharmaceutical dossier
  

• Master in pharmacy – junior profile accepted
  

• Knowledge of medical devices regulations
• Knowledge on Materiovigilance/pharmacovigilance
• Microsoft Office, knowledge of traceability and complaints treatment systems desirable eg. SAP
  

• Autonomy
• Punctuality / Strictness
• Priority management
• Insight into organization & planning
• Analytical & synthetic spirit
• Communication skills
• Editorial and relational qualities
• Team player
  

• Dutch required
• Professional English proficiency required (reading, writing, speaking)
• French is nice to have
  

• Type: Full time
• Location: BEL - Zaventem