Quality Auditor

з/п не указана

Вакансия в архиве

Работодатель, вероятно, уже нашел нужного кандидата и больше не принимает отклики на эту вакансию

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Требуемый опыт работы: 1–3 года

Полная занятость, полный день

Job Responsibilities:

  • To manage on-site audits and Quality Questionnaires, related to Suppliers, Third Party Manufacturers & affiliates for GxP and Pharmacovigilance (PV) that fall under the responsibility of EPD QA (EPD Affiliate and Veropharm).
  • To manage internal audit (self-inspections) for Veropharm manufacturing sites and commercial affiliates (EPD and Veropharm)
  • To perform regular Regulatory update to be sure that current GxP and licensing requirements are known, and shared on the regular base.
  • To establish and maintain the system for insuring of External Inspections and AQR audits readiness of Veropharm manufacturing sites and commercial affiliates (EPD and Veropharm).
  • Provide support to regional EPD plants, affiliates and Contract Operations QA in the timely resolution of issues related to Suppliers and Third Party Manufacturers.
  • Actively participates on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations.

Job Requirements:

  • University (high) education at a relevant scientific discipline or other technical/scientific, or industry experience with sufficient exposure to pharmaceutical or related industries.
  • ISO Certified Quality Auditor (CQA) Certified Quality Engineer (CQE), or other international certification desirable (as a big plus).
  • At least 5 years in the Pharmaceutical Industry and/or related industries; and at least 3 years of GXP Auditing experience, with a minimum of 2 years Lead auditor experience in GxP, Pharmacovigilance or ISO.
  • Knowledge and understanding of the relevant GxP, PICs, ICH, WHO, Pharmacovigilance and other relevant technical guidelines, Russian legislation.
  • Ability to communicate, understand and mentor individuals in highly specialized technical fields.
  • Project Management and troubleshooting skills.
  • Advanced written and verbal skills in Business English.

We offer:

  • Work with a highly professional team.
  • Opportunity of professional and career growth.
  • Medical and life insurance.


Москва, м.Кожуховская
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Вакансия опубликована 15 апреля 2019 в Москве

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