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Вакансия в архиве
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- 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.
- 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.
- Work with a highly professional team.
- Opportunity of professional and career growth.
- Medical and life insurance.