Фармацевтическое подразделение компании, Janssen, занимается поиском решений для таких серьезных проблем современной медицины, как онкология, иммунология, психиатрия, а также инфекционные, сердечно-сосудистые заболевания и нарушения метаболизма. Janssen является последовательным сторонником и проводником инновационных решений для здравоохранения и уделяет огромное внимание повышению доступа пациентов к современным лекарственным средствам.
Responsibility for full support of declaration/certification and State selective control of Janssen products: planning, preparation, standards and reagents order, import permission obtaining, application submission, sampling, monitoring, certificate/declaration obtaining, tracking. Planning of certification/declaration procedures in co-operation with Regulatory team, Supply Chain Dep and support of Quality Management System in Janssen Russia and CIS to ensure that all locally marketed products and all local processes are in compliance with all applicable Johnson & Johnson and local regulation requirements.
Preparation for certification/declaration in accordance with certification center/laboratory requirements
Planning and execution of inspection control for the products certified by scheme 5
Participation in certification optimization schemes, cooperation with certification center and manufacturing sites, preparation for inspection on manufacturing sites
Translation of certificates of analysis for commercial batches
Check of the quality declarations for correctness from the Regulatory point of view
Preparation for state selective control in accordance with RZN/laboratory requirements
Standards and reagents order in accordance with laboratory request
Communication with contacts in HQ and partners for obtaining necessary documents and materials, negotiations in case of any specific cases/issues.
Maintaining good relationship with RZN and laboratories
Submission of samples, materials and documents in laboratory
Monitoring of testing process in laboratory
Communication with RZN on state selective control outcome
Creation and maintenance of local quality documentation
Support in trainings for employees located in Russia and CIS with proper effectiveness check verification and maintenance of related training records
Quality assessment and approval of CCDS related change control records in respective e-system
Events/deviations management from initiation to closure incl. quality assessment and approval in respective e-system
Complaints management from initiation to closure incl. issue closure review
Monitoring of informational letters related to locally marketed products at RZN site
General understanding of certification/declaration