Local Manufacturing&GMP Specialist

по договоренности
Опыт работы не важен


Our client, the world's leading pharmaceutical and diagnostic company, one of the largest manufacturers of biotechnological medicines invites to take part in the competition for the vacancy Local Manufacturing&GMP Specialist

Job Responsibilities:

  • Full responsibility for preparation of regulatory submissions for Russian manufacturing sites registration (fill&finish and secondary packaging) which requires cross-functional collaboration with HQ and external partner
  • Assist to HQ and local partners in terms of audit preparation activities, reference standards and critical reagents order process
  • Support of analytical transfer activities
  • Interaction with HQ and local partner on quality related topics
  • GMP inspection scheduling in cross-functional collaboration with appropriate groups and HQ
  • Preparation of GMP application including documents request, translation verification and submission to MoIT with requests follow up
  • Site inspection preparation in close collaboration with site inspection management and Global Inspection management group (gap assessment, observations follow up, site pre-visit)
  • On-site inspection support (translation, issue management, regulatory follow up)
  • Post inspection management (additional materials submission, clarification of remaining questions, CAPA alignment)
    • Work Environment:

    • Compensation is discussed individually.
    • Extended social package (VMI, mobile, laptop, fitness etc.).
    • Professional growth is one of the corporate values.
      • Requirements:

      • Knowledge in DP/API manufacturing, QC, QA, development and manufacturing sites audit
      • Regulatory Affairs experience
      • Good knowledge and understanding of implementing regulatory requirements, including GMP, ICH requirements, Russian and EAEU requirements
      • Excellent organizational, communication and interpersonal skills
      • Ability to work on a number of projects with tight timelines
      • Agility
      • Ability to act and mitigate critical situations
      • Fluent in English both verbal and written
      • Readiness to frequent business trips (at least once per month)
        • Тип занятости:

          Полная занятость, полный рабочий день, у работодателя

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