от компании (организации): Antal Russia в городе (населённом пункте): Москва, Россия
в отрасли экономики "Производство, сельское хозяйство" → "Фармацевтическая промышленность"
с заработной платой: по договоренности
Вакансия № 22072008 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Вторник, 6 августа 2024 года.
Дата обновления вакансии № 22072008 на сайте Работа в Москве и Московской области (МО, Подмосковье): Суббота, 21 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 22072008 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: Quality Consultant
Responsibilities:
- Assure the robust selection and on-boarding of Third Parties in compliance with both the regulatory/GMP requirement, in alignment with Company Global Quality Standards and relevant procedures.
- Support and provide Quality input for qualification and validation activities at Third Parties and product launches.
- Manage and support change control activities at Company and with Third Parties.
- Support Regulatory submissions.
- Drive the utilization of Risk Management principles for third party oversight.
- Implement and maintain Quality Agreements with Third Party Suppliers in accordance with the relevant regulatory requirements, the Company Global Quality Standards and relevant procedures.
- Monitor Supplier/Contract Manufacturer or third party KQI’s to proactively detect compliance issues on supplier level in order to resolve them before they become problematic from a GMP and regulatory compliance/supply perspective.
- Assure investigations are performed at Third Parties to GMP standards, to determine the quality impact on products and assure appropriate corrective and preventative measures.
- Schedule and follow up on audits at Third Parties and Suppliers including monitoring of corresponding corrective actions, in line with the global auditing team requirements/timelines.
- Evaluate supplier Product Quality Reviews/ Annual Product Reviews to pro-actively analyze and monitor quality trends on supplier level including the implementation of necessary corrective actions.
- Assure in association with other relevant personnel that Product Quality Reviews/Annual Product Reviews are completed according to the required timelines.
- Implement continuous improvement initiatives associated with quality systems to ensure they are both robust and effective and enable appropriate levels of supplier monitoring and product quality performance.
Requirements: - Formal Education in Science (Diploma, Master or equivalent education).
- Excellent command of English
- Several years experience in Quality Assurance or Pharmaceutical Production of Medicinal goods under GMP requirements.
- Thorough knowledge and understanding of Regulatory requirements.
- Working experience within a global organization.
- Minimum 5 years of experience in local and global QA operations.
Conditions: - A generous compensation package depending on the experience and educational background;
- Career and development opportunities in reputable American Company;
- Excellent working environment, office in the center of Moscow.
Откликнуться на эту вакансию: Quality Consultant
Предыдущая вакансия:
Вакансия № 22072005 на должность Заместитель начальника цеха (производство лекарственных препаратов) от компании ЗАО Канонфарма продакшн в городе (населенном пункте) Щелково