от компании (организации): Abbott Laboratories в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Лекарственные препараты"
с заработной платой: по договоренности
Вакансия № 21900420 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 23 сентября 2024 года.
Дата обновления вакансии № 21900420 на сайте Работа в Москве и Московской области (МО, Подмосковье): Среда, 13 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 21900420 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
3–6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Regional Quality Systems Specialist Russia-CIS
The Job:
Regional Quality Systems Specialist will contribute to building and maintenance of QMS in RU-CIS Abbott Region in compliance with Abbott standards and with current legislation locally as well as internationally.
Quality Assurance and QMS maintenance:
- Support responsible area(s) in critical Quality-processes including, but not limited to document control, quality training program, non-conformities, CAPA, internal audits and external inspections
- Stay aware on updates in regulatory requirements related to Regional QMS in the supported markets
- Assist QS Manager in periodic QA management meetings and respective data collection in area of responsibility
- Act as Regional SME for IT QA systems (Documentation, Training, NCR and CAPA), provide trainings within Regional QA organization on QA electronic systems user roles
- Contribute to Regional and Divisional QMS projects and initiatives
Maintenance of RU-CIS Regional QA Training System:
- Under guidance of Regional QS Manager identify training needs for Regional QA Organization through the respective functional leads/heads;
- Facilitate/arrange training Modules/Curricula for identified training needs; assign trainings in electronic system, reconciliation of missing training requirements and past due training sessions;
- Keep regional QA training matrix up to date and perform annual revision and actualization of assigned training plans together with respective functional leads
- Prepare training Metrics/KPIs for Regional QA Organization employees and circulate to Senior Leadership
Regional QA Documentation:
- RU-CIS QA Regional Documentation and Records management and distribution
- Manage periodic revision schedule for Regional SOPs/ Guidelines
- Assist QA document owners and authors in workflows processing in electronic Document Management System
- Develop and implement regional QMS SOPs as applicable in the area of responsibility and ensure they are reviewed by appropriate staff and departments and conform to corporate standards
- Maintain Regional QA Documentation Index
Audits and External Inspections
- Follow-up on exceptions and non-conformities raised during regional and corporate QA audits
- Raise and investigate exceptions and non-conformities in the area of responsibility; develop and execute appropriate CAPA plans
- Support Affiliates within Region in preparation to regional and corporate audits
- Support Regional QS Manager in local GMP certification program (technical support to the sites during inspection readiness activities; local applicant representation on site during inspections, monitoring of sites CAPA plans execution, collection and translation of respective closure evidences and their submission to the authority)
Qualifications:
- Degree in engineering field or Chemistry/Biochemistry/Microbiology or Computer Science
- Experienced user of electronic systems (for documentation or process management)
- English fluent/upper-intermediate
- High proficiency with MS Office, Windows, SharePoint, ) with demonstrated skills in the use of word processing, spreadsheets, databases & information management systems additional eQMS knowledge is a plus
Work experience:
- 3-5 years of experience in GMP or ISO regulated industry
- Assiduity, attention to details, ability to process and analyze big volumes of data in multiple systems
- Ability to proactively anticipate multiple deadlines, and drive and manage project priorities
- Excellent interpersonal skills and the ability to interact with staff on all levels and within a culturally diverse environment
Откликнуться на эту вакансию: Regional Quality Systems Specialist Russia-CIS
Предыдущая вакансия:
Вакансия № 21900413 на должность Оператор в почтовое отделение работа рядом с домом срочно! от компании «Почта России», Офис в городе (населенном пункте) Москва