Вакансия № 2623541 на должность "Clinical Quality Assurance Director" в городе (регионе) Москва, Россия от компании "ООО AB Services" на сайте Электронный Центр Занятости Населения
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Организация работает в следующих сферах деятельности: Услуги для бизнеса; .
Репутация компании "ООО AB Services" в отзывах работников:
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Обязательное требование к опыту работы искомого сотрудника: 3–6 лет.
График работы: полный день.
Тип занятости: полная занятость.
Вакансия № 2623541 добавлена в базу данных: Среда, 17 апреля 2024 года.
Дата обновления этого объявления: Пятница, 19 апреля 2024 года.
Рейтинг вакансии: 8,19 из 100 баллов |
Вакансия № 2623541 прочитана - 186 раз(а)
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Вакансии Мультирегионального Электронного Центра Занятости Населения в социальных сетях и мессенджерах:
Работодатель предложит заработную плату по результатам собеседования с соискателем работы.
Our client is a premier international contract research organization that specializes in clinical trials in Central and Eastern Europe and CIS – the areas with the most compelling environment for biopharmaceutical research is looking for a Quality Assurance Director
Qualifications
- a degree in life sciences, medical sciences, pharmaceutical field or similar and also in management;
- at least 5 years of experience in the relevant field, 2-3 years of monitoring;
- Previous relevant experience in Quality Assurance Manager or higher position within CRO/pharmaceutical company;
- knowledge of ICH GCP and national regulations related to clinical trials;
- excellent command of written and spoken English language;
- excellent record retention, customer service, and interpersonal skills;
- ability to work under time constraint; ability to establish and meet priorities, deadlines, and objectives;
Your tasks:
- ensuring that all processes contributing to the performance of a clinical trial are conducted in accordance with ICH guidelines and other regulations;
- implementing internal Quality review processes including developing and monitoring measurements of success;
- coordinating activities of Quality Department and subordinate staff;
- participating in reviewing and reporting findings and recommendations to senior management;
- preparing Quality Audit Programs and leading the internal and external quality audit process;
- providing Quality Assurance and Quality Control surveillance and support to projects to ensure adherence to quality plans;
- managing the development of Total Quality Measurement system;
- coordinating and assisting to cross-departments during the preparation of standard documents;
- preparing standard documents relevant to scope of activities of Quality Department;
- reviewing problems and procedures of departments and recommending solutions or changes in procedures;
- controlling the status of the quality levels of staff, systems and production activities and participating in improvement programs;
- participating in the evaluation of quality events, incidents and possible complaints and the follow-up activities;
- obtaining client’s feedback;
- keeping up to date with all related quality legislation and compliance issues;
- representing the company during external audits/inspections and coordinating preparation process;
- conducting management meetings to establish, delineate, and review organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures;
- maintaining the internal audit system;
- conducting internal system, process, documentary, on-site project audits and vendor audits;
- preparing Audit Reports and CAPAs. Controlling of CAPA implementation for internal and external audits;
- following all applicable requirements of Company’s standard documents and applicable legislation requirements.
We offer:
- competitive salary and bonuses (to be discussed with the successful candidates);
- an intelligent working environment in fast growing international company;
- cheerful, friendly and enthusiastic team with positive attitude;
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