от компании (организации): ANCOR в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Производство"
с заработной платой: по договоренности
Вакансия № 18829331 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 17 августа 2024 года.
Дата обновления вакансии № 18829331 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 22 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 18829331 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
1–3 года
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Специалист по обеспечению качества / Quality Assurance Specialist
Наш клиент, международная фармацевтическая компания-производитель, в поиске Quality Assurance Specialist.
Reporting to the QA Head Russia & CIS, the purpose of the Quality Specialist role is to support the QA Head in the performance of Quality and Compliance tasks for Russia with regards to international and local GMP and GDP requirements (including Medical Device guidelines).
Support the QA Head with the implementation of the defined Global Healthcare Operations strategy and ensure the implementation and monitoring of the Quality Management System and their continuous improvement.
Tasks will include the management of product release to the market (back-up local QP for releasing of imported products to the market as of Federal Law 449-FZ), documentation, metrics / trend reports for both complaints and deviations. In addition, this role will provide assistance with the management of complaint management activities e.g. reporting, trend analysis etc.
Another key area of this role is the maintenance and creation of Standard Operating Procedures and Work Instructions, aligned with HCQ requirements; ensuring documents are available in documentation system.
Key Responsibilities::
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Manage the Complaints Process including the investigation process. Maintenance of all appropriate documentation, recording and investigation of customer complaints via the complaint database; return of complaint samples to manufacturing sites for investigation purposes and provision of information to complainants as required (complaint responses).
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Change Control, Deviation and CAPA management including data entry into the electronic system.
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Responsible for the compilation, tracking and sharing of trend reports, working with stakeholders to propose appropriate CAPAs.
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Assist with the creation and maintenance (periodic review) of Quality Standard Operating Procedures and Work Instructions and ensuring procedures are available via documentation system.
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Assist QA Head in the assessment of the Global Quality Procedures and WI on the applicability to the local Quality System.
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Product Release: responsible for release of shipments including documentation review of shipping documents, product certificates and temperature loggers. QA release of shipments in local ERP system.
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Back-up local QP (QA Head) for releasing of imported products to the market as of Federal Law 449-FZ. Ordering and purchasing of reference standards and lab materials necessary for the full analysis of imported products once per year. Communication with laboratories for standards and materilas demands and provision of those.
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Particpate in the Right First Time objective as part of product release activities and work with stakeholders to share the information and improve local processes as necessary.
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Assist with preparing training presentations as needed e.g. for relevant GxP SOP’s & WI’s.
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Assist with audit management planning and execution including the tracking of CAPA plans through to closure.
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Assist with suppliers qualification and assessment.
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Assist in QA operations related to local pharmaceutical warehouse.
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Assist with Risk Management activities
Requirements:
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Background in Pharmacy, Chemistry, Life sciences, Pharmacology, Medicine or a related scientific discipline or other related field.
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Background in Medicinal product distribution highly desirable
Job Specific Competencies & Skills / Work Experience
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Preferrably at least 3 years' experience related to Pharmaceutical or related industry, ideally with a mix of Manufacturing / Quality operations, Distribution Warehouse management or other related activities.
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Experience in Good Distribution Practices.
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Knowledge in local laws and local regulations applicable to the operation
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Ability to work within a team environment and with cross functional teams.
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A demonstrated proactive, problem-solving mentality with strong analytical skills
Откликнуться на эту вакансию: Специалист по обеспечению качества / Quality Assurance Specialist
Предыдущая вакансия:
Вакансия № 18829326 на должность Комплектовщик склада интернет-магазина OZON от компании Stockroom logistics в городе (населенном пункте) Москва