от компании (организации): ANCOR в городе (населённом пункте): Москва, Россия
в отрасли экономики "Производство, сельское хозяйство" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 22654908 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 18 августа 2024 года.
Дата обновления вакансии № 22654908 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 № 22654908 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: GMP Specialist
Наш клиент, международная фармацевтическая компания-производитель, в поиске GMP Специалиста (GMP Specialist).
Reporting to the QA Head Russia & CIS, the purpose of the GMP Specialist role is the support to QA Head in the performance of GMP inspections of the company manufacturing sites, registered in Russia. Support in activities that may raise with regards to CIS GMP inspection topics.
Key Responsibilities
- Control of GMP inspections timelines and schedule, adhere to the plan with regards as well to regulatory submissions in Russia and EAEU countries.
- Preparation of the applications and materials for GMP inspections to the Ministry of Industry and Trade and performing the routine communication with GILS and inspectors on the operational part.
- Communication with the manufacturing sites for the planning, preparation for the inspections. Participation in inspections together with QA Head.
- Communication with the sites and inspectors with regards to the CAPAs planning, performing and closure.
- Risk assessment activities where needed.
Cooperation / Collaboration
Internal
- Local Regulatory and other stakeholders
- Manufacturing sites
- Global Regulatory Affairs, where needed
- Corporate QA, R&D QA Affiliates, Healthcare Quality Functions
- Local Marketing / Sales
- Local Medical Affairs, if needed
- EAEU QPPV, if needed
- Local Patient Safety Responsible Person (LPSR)
- Local legal
External
- Ministry of Industry and Trade
- GILS
- Other entities, where needed
Candidate's Profile
Education
- Background in Pharmacy, Chemistry, Life sciences, Pharmacology, Biotechnology, Biology, Medicine or a related scientific discipline or other related field
- Background in Medicinal product manufacturing and/or distribution is highly desirable
Job Specific Competencies & Skills / Work Experience
- Preferrably at least 2 years' experience related to Pharmaceutical or related industry, ideally with a mix of Manufacturing / Quality operations or other related activities
- Experience in Good Distribution Practices
- Knowledge in local laws and local regulations applicable to the operation
- Willingness and enthusiasm to learn new skills
- Time management skills, ability to prioritise and work in a busy work environment
- Excellent communication skills
- Ability to work within a team environment and with cross functional teams
- A demonstrated proactive, problem-solving mentality with strong analytical skills
- Accontability
ADDITIONAL REQUIREMENTS
- Computer skills (Word, Excel, SharePoint, etc.)
- Knowledge of software packages such as Trackwise, Documentation Management systems desired, but not essential
Откликнуться на эту вакансию: GMP Specialist
Предыдущая вакансия:
Вакансия № 22654907 на должность Официант в ресторан "Чайхона №1", Балашиха от компании Чайхона №1 Братьев Васильчуков в городе (населенном пункте) Балашиха