от компании (организации): Kelly Services в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 20092983 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 17 августа 2024 года.
Дата обновления вакансии № 20092983 на сайте Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 23 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 20092983 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
не требуется
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: In-Market QA Junior Specialist
Our client international pharmaceutical company is looking for In-Market QA Junior Specialist
You will be supporting the Senior Specialist Quality Assurance with activities related to the local batch release process, namely supporting the introduction of imported Medicinal Products for Medical Use into Civil Circulation in accordance with local legislation (FL-449).
The primary activities may include but are not limited to:
- Collaboration with Commercial and State laboratories in terms of execution of necessary tests and management of standards and reagents
- Translation into English of CoA for imported batches of medicinal products
- Ensure the accuracy and quality of the records related to Local Batch Release process
- Work with Reference Standards (including in-house standards), reagents, consumables, etc. that are necessary for testing, namely:
- Order management
- Importation process
- Customs clearance
- Warehousing
- Delivery management (including hand-over process)
- Stock control (keeping safety stock at enough level, control of expiry dates, replacement of expired materials etc.) and stock reconciliation (for both MSD and state/commercial labs)
- Assisting or leading the development, and ongoing execution of the Quality Agreement with Broker, State and Commercial laboratories and service providers.
- Developing and maintaining Power of Attorneys (internal and/or with 3rd party service providers)
- Organize and maintain system of storage, archiving and (where necessary) retrieval of necessary records related to duties entrusted
- Collaboration with Broker and Suppliers of Standards on activities related to standards and reagents management
- Coordinates all financial documentation and reporting on duties entrusted
- Collaboration with Commercial/State laboratories, Broker and Commercial Standards Suppliers (if needed) in terms of contracting (prolongations)
- Track and monitor operational and quality performance of the Commercial/State laboratories and Broker
- Assure compliance with established MSD policies/procedures and comply with all applicable governmental regulations (GMP, GDP, local legislation, etc.)
- Supporting (assisting) Senior Specialist Quality Assurance in actions related to problem solving and handling of non-conformities and deviations revealed during local batch release process.
- Assures all actions on duties entrusted are timely executed in order to prevent stock out situation in the market
- Participates in EHS, Business Compliance, cGMP/GDP and all other compliance-related matters, where applicable.
- Ensures both operational knowledge and technical skills are maintained, and individual training requirements are met
Qualifications
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.
- Competent in scientific problem solving and risk analysis capabilities.
- Strong compliance mind-set, demonstrated interpersonal skills, including leadership and coaching, motivation, communication and negotiation. Demonstrates organizational skills, is proactive and self-motivated with ability to multi-task.
- Some level of contractual and financial awareness is preferred.
- Planning skills
- Proficiency in Russian and English (at least intermediate)
Откликнуться на эту вакансию: In-Market QA Junior Specialist
Предыдущая вакансия:
Вакансия № 20092975 на должность Консультант-Специалист/Оптометрист в магазин оптики (ТРЦ БУМ) от компании ООО АЙКРАФТ в городе (населенном пункте) Москва