Quality Manager Manufacturing
Вакансия № 2505305 в населенном пункте (городе) Москва, Россия от компании "Brainpower CIS" на сайте Мультирегиональный Электронный Центр Занятости Населения (ЦЗН).
Уважаемый соискатель вакансий, Вы можете перейти на сайт прямого работодателя "Brainpower CIS" для ознакомления с информацией о компании (фирме, организации, ИП). Смотрите Веб-сайт "Brainpower CIS" - http://www.brainpower.ru/
| Логотип (торговая марка, бренд, эмблема, внешний вид здания или внутренний интерьер офиса): |  |
Организация работает в следующих сферах деятельности: Услуги для бизнеса; .
Репутация компании "Brainpower CIS" в отзывах работников:
Читайте свежие отзывы сотрудников об этой организации на этом сайте.
Оставить мнение об этом работодателе без регистрации бесплатно на этом сайте.
Обязательное требование к опыту работы искомого сотрудника: 3–6 лет.
График работы: полный день.
Тип занятости: полная занятость.
Вакансия № 2505305 добавлена в базу данных: Пятница, 12 апреля 2024 года.
Дата обновления этого объявления: Пятница, 26 апреля 2024 года.
| Рейтинг вакансии: 10,56 из 100 баллов |
Работодатель предложит заработную плату по результатам собеседования с соискателем работы.
Our Client – Innovative multinational biopharmaceutical company
Reporting line: Global Quality Director
Location: Moscow
Domestic and International travel will be required
Essential Duties and Job Functions:
- Supporting GMP manufacturing, testing, storage and transportation of commercial products
- To be the primary Quality Site/Product Lead for partner manufacturers and serve an integral role within a cross-functional leadership team (that includes members from Russia, International Quality, Contract Manufacturing, QC laboratories, Process Development and Supply Chain)
- Responsible for Quality oversight of activities at Partner organizations, including, tech. transfer, review and approval of Company specific technology transfer documents, analytical method transfers, NC/CAPa, change controls, procedures and reports.
- Serves as the main Quality point of contact for deviations, change controls, author and revision of quality agreements and batch disposition etc. related to Company product.
- Manage partner to contractual obligations relative to Quality Agreement, Company specifications, quality, safety and regulatory requirements.
- Review completed production batch records as necessary and approve master batch records, and other cGMP documents.
- Identify and mitigate Risk and escalate risks or roadblocks to management
- Monitor and communicate site performances in means of quality metrics to Company and Partner
- Supports regulatory inspections of Company and Contract Manufacturing sites by Russian GMP Inspectorate.
- Serves as a backup for the responsibilities related to in-country certification, ensures reference standards and reagents supply for in-country certification. Regularly interacts with local authorities, certification laboratories and certification centers.
- Serves as a backup for Country Quality Specialist for Company Russia, complaint intake, training of local staff on complaints and brand protection.
- Maintains quality systems at Company Russia affiliate, Support investigations/deviation reports
- Participates and leads due diligence activities in Russia and CIS, as required
Specific Responsibilities and skills for Position:
- Education: Degree in Chemistry, Chemical Engineering, Biochemistry, Biotechnology, Pharmaceutical Engineering (or Technology) and Biology or related technological field
- 3 or more years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry, preferably – experience with biologics, vaccines
- Experience with aseptic processing, lyophilization, fill/finish, packaging and labeling
- Must have strong knowledge and understanding of GMP pharmaceutical manufacturing, GDP requirements, cold chain transportation and storage, local regulatory requirements.
- Experience with technology and analytical method transfer, writing of protocols and reports, batch record design, review, raw material and product release
- Regulatory knowledge for Russian environment
- Experience in regulatory inspections
- Experience in pharmaceutical equipment qualification, risk assessments, change control
- Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
- Interacts effectively with variety of communication and working styles and teams
- Interact effectively with cross functional team
- Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality
- Very good level of English - technical writing and verbal communication/presentation
- Russia citizenship
Разместить Ваше резюме сейчас ...
Написать в компанию ...