Обязанности:
You will be a part of Distribution & In-market Quality Team responsible for activities related to Good Distribution Practice (GDP), license maintenance and local batch release process for Russian market, quality support for CIS markets Main responsibility: Assure compliance with established Company’s policies/procedures and comply with all applicable governmental regulations (GMP, GDP, local legislation, etc.) Maintain the local Quality Management System Participation in Audits and Self-inspections Ensure Quality training of personnel including assessment of training effectiveness Complete trainings as required for role Handling of product quality complaints (PQCs) Participation in deviation management, overview and tracking, handling of temperature excursions during transportation, warehousing and distribution Participation in CAPA management, including tracking Participation in local recall coordination and execution Local batch release (routine and one batch per year) – AIS RZN, release in SAP Collaboration with laboratories Coordination of product testing between manufacturing site and CIS state laboratories, including management of any resultant investigations or queries Quality Agreements with providers and KPIs monitoring Product Quality Reviews Qualification Education: University Degree in a relevant science (preferably BS Pharmacy, Chemistry, Chemical Engineering, Biology (or equivalent) education) Basic knowledge of normative documentation, medicines state registration process, local pharmacopeia articles Basic knowledge of quality confirmation/local certification Experience and knowledge in the field of logistics (importation, customs clearance, warehousing, transportation including cold chain) Experience in the field of GMP/GDP and other applicable local legislation is preferable Skills Required: At least 2 years’ experience in the pharmaceutical industry preferably with knowledge of Quality Systems, Quality Assurance and Quality Control including basic knowledge of global GMP/GDP and regulatory requirements. Strong compliance mind-set, motivation, communication and negotiation, multi-task. Some level of contractual and financial awareness is preferred. Excel spreadsheets, SAP, ETQ English (at least intermediate)Похожие вакансии
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