Обязанности:
PURPOSE OF THE ROLE QA Director for Russia & Eurasia is responsible for leading Quality Assurance department, building & maintaining Quality Management system, defining and promoting quality mindset across organization, working cross-functionally to deliver products under required quality standards WHAT YOU WILL DO Managing QA employees, setting goals, monitoring of execution Organization of creation, implementation and maintenance of Quality Management System including GDP requirements as well as requirements of Teva Corporate Policies and Standards Ensure GMP & GDP compliance at the commercial unit and promote the quality culture Development and monitoring KPIs to measure effectiveness of Quality Management System Organization of quality audits of local GMP/GDP-related services providers Organization of EAEU GMP audits for foreign manufacturing sites, supporting manufacturing sites for preparations to inspections Organization of processes for products release, state/random Quality Control, recalls, handling of deviations & complaints, change control, CAPA management Interactions with State Authorities with respect to GMP/GDP compliance, reporting of quality deviations, recalls Identification areas of improvements and develop strategies to address the areas Collection and analyzing data to identify trends and opportunities for improvement Creating and distributing of reports with respect to QA KPIs to local management and Regional/Global QA organization Ensure the market release from approved suppliers based on local regulations, batch release documentation and transport conditions documentation Ensure the distribution traceability of finished products and returns of products commercialized in the country Ensure the GDP compliance of the distribution centers Ensure that quality complaints are registered and liaise with manufacturing site to trigger corresponding investigation and adequate corrective actions. Liaise with pharmacovigilance department if necessary In case of recall ensure the local coordination between PhV, Medical Affairs, Regulatory Affairs, Supply Chain and with site Quality Head/ EU Qualified person concerned. Escalate any critical information to Regional Head of Commercial Quality and issue the final recall Report to Regional Quality and local management any critical quality incident Host and lead GMP/GDP related competent authority inspections Perform or coordinate internal audits of the compliance of the Quality System Perform or coordinate external audits, with respect to quality related matters, of local warehouses/distributors and other local suppliers/service providers as per Teva standards WE EXPECT 5+ years experience in the similar role University degree of Pharmacy/Medicine/Chemistry/ Biotechnology/ Biology Experience in managing a cross functional quality team Outstanding leadership and partnering competences Advanced analytic and structured problem solving competences Well developed business management, negotiation and customer relationship building skills Strong convincing, communication and customer relationship skills Solid knowledge and experience of quality legislation, industry standards and guidelines in Russia, Kazakhstan, other CIS with respect to medicines, food supplements, medical devices, cosmetics Self-motivated and independent Ability to meet deadlines under pressure Critical & systems thinking and risks management skills Excellent communication skills (verbal and written) Fluent in written and spoken English Strong organization/planning skills and ability to manage multiple concurrent projects Proven experience in execution: ability to bring strategy to a tactical level and get projects started and completed Proven track records of tangible achievements Demonstrated ability to lead without authority High ethical standards and personal integrity WE OFFER Working in a beautiful office in the center of Moscow in a hybrid format: 3 days from the office and 2 days from home Taking care of you and your loved ones: Extended insurance programs (life insurance, health insurance with dentistry for you and one close relative) Additional payment for sick leave 5 additional paid vacation days per year Remote psychological assistance from RESO Discounts and special offers from the company's partners Competitive social package: Food subsidy Payment for mobile communications Laptop Corporate car or car allowance Professional development: Corporate training and development programs Individual development plan for each employee Corporate online library Engaging corporate life: Online communities to support your hobbies and find like-minded people Corporate Volunteering program Corporate parties and events Summer internships for employees' children Webinars with internal and invited speakers And much more!Похожие вакансии
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