от компании (организации): VALEANT в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Производство"
с заработной платой: по договоренности
Вакансия № 735376 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 9 ноября 2024 года.
Дата обновления вакансии № 735376 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 10 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 735376 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: Quality Assurance specialist (GMP)
RESPONSIBILITIES
Quality Management System (QMS) Building
- Writing/updating SOPs and operational instruction;
- Track the SOPs list/QMS Plan – control of timely implementation and updating;
- Carrying out/control/documentation actions for CAPA, Deviations, Change control (etc.) processes
- Documentation management
Quality Compliance
- Site Quality Plan implementation;
- Responsible for trainings:
- For newcomers;
- Annual trainings for all staff (including development of trainings);
Quality Assurance Agreements (new/updates)
- Database update and maintenance.
Quality audits/checks
- Internal audits.
- Support activities if required (administrative/organizational).
Product Quality issues
- Preparation of official letters;
- Routine daily checks of HA database (check the presence of official prescriptions);
- Documentation (registration in the file, printing, archiving).
- Conclusion of contracts with laboratories/service suppliers (for purchasing chemical reagents, reference standards);
- Organization of independent expertizes in laboratories upon VALEANT initiative
GMP-inspections /(Inspections of MD Manufacturing Sites in future)
- Development of templates and list of documents to be provided on the basis of local legislation requirements;
- Requesting the documents;
- Checking the accuracy and completeness of provided documents;
- Communication with MS/EMQA;
- Control the statuses on each stage of process (from the requesting docs till the receiving GMP-certificate);
- Collaboration with inspectors and experts of Ministry of Industry and Trade;
- Control of application statuses in Ministry of Industry and Trade;
- Coordinate the concluding of contracts and paying for state service of inspection.
- Collaboration with compliance in terms of paying for inspection;
- Tracking and coordination of inspection schedules;
- Supporting all the activities in terms of project.
- Participation in inspections;
- Control of CAPA preparation and closure.
Local declaration process
- Support updates/changes in CoAs if required.
CIS
- Support for quality queries;
- Ordering reference standards upon request;
QA projects
- Cross functional collaboration in projects with QA involvement;
- Consulting on quality GMP topics;
JOB REQUIREMENTS
- Work experience: 1-2 years in pharmaceutical company in Quality Assurance field
- English language: intermediate / upper-intermediate
- Education: higher education (chemistry, biology, pharmacy specialization)
- Additional: stress-resistance, multitasking skills, PC advanced user, knowledge of local and international standards, the possibility for business trips (warehouses in Moscow district)
- Strong knowledge of local legislation, international standards and practices for manufacturing and distribution of medicinal products and medicinal devices.
Откликнуться на эту вакансию: Quality Assurance specialist (GMP)
Предыдущая вакансия:
Вакансия № 735323 на должность Лаборант / Работник вивария от компании Биалекса в городе (населенном пункте) Москва