Quality assurance specialist

по договоренности
Опыт работы не важен


Lead international pharmaceutical company.

Job Responsibilities:

  • Primary quality representative in an active/direct relationship with a Third Party pertaining to Quality
  • Provide technical expertise and hands-on presence and additional resources to support quality and compliance
  • Maintains an effective Quality Technical Agreements
  • Ensure validation activities are supported for products, new equipment, new processes and changes to existing methods and that all requirements are met for the product, process equipment and facility
  • Ensure change control processes are operated in a timely and accurate manner
  • Assess quality and regulatory impact of significant events and internal trends to determine potential impact to the business
  • Ensure key performance indicators are established and implemented for quality systems
  • Facilitate Quality Management Review meetings
  • Provide support for external regulatory audits, internal audits and quality initiatives.
    • Work Environment:

    • Office - Belorusskaya metro station.
    • Corporate trainings, professional courses in Europe.
    • Wide benefits, high salary.
      • Requirements:

      • Education: Higher in an Engineering or Science discipline
      • Certified Quality Auditor, other international certification
      • Significant manufacturing related experience in a Regulated Environment (preferably Drug Products), in all aspects of a Quality organization 5 years as a minimum
      • Capable of independently analyzing data in order to develop strategies to effectively manage the action plans that will resolve the issues
      • Strong project management and troubleshooting skills
      • Ability to communicate, understand, and direct individuals in highly specialized technical fields
      • Ability to communicate effectively in English (upper intermediate level and higher)
      • Extensive knowledge of key Local and Global regulations
        • Тип занятости:

          Полная занятость, полный рабочий день, у работодателя

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