Local Manufacturing&GMP Specialist

по договоренности
Опыт работы не важен

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

          Подпишитесь на подходящие вакансии