Certification and Quality specialistВакансия в архиве

Уровень зарплаты
з/п не указана
Город
Москва
Требуемый опыт работы:
1–3 года
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.

Responsibilities:

  • 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

Requirements:

  • Higher education
  • General understanding of certification/declaration
  • English (Intermediate and higher)
  • MS Word – working level, MS Excel – basic
  • Detail-oriented, structured, organized

Тип занятости

Полная занятость, полный день

Адрес

Крылатское, Москва, Крылатская улица, 17К3
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