от компании (организации): ООО Берлин-Хеми/А. Менарини в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Клинические исследования"
с заработной платой: по договоренности
Вакансия № 10507358 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Четверг, 24 октября 2024 года.
Дата обновления вакансии № 10507358 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 № 10507358 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: Qualified Person (Quality of medicinal products)
Main tasks:
- checks the compliance of each imported batch with regard to the approved ND/RU Pharmacopoea based on the CoA issued by the manufacture of the medicinal product.
- checks, confirms and documents the compliance of each imported batch with the requirements of the relevant product MA in RU
- provides Rozdravnadzor with all information in accordance with the requirements in the Federal Drug Law as the precondition to be fulfilled prior the distribution of the batch in the territory of the Russian Federation
- To fulfill these duties and responsibilities the position holder is authorized to cooperates with authorities and external partners provided corresponding company group rules and procedures are considered. If necessary to organize the sampling of the medicinal products when the batch arrives the warehouse of the distributor
- Clarifies with the QP of the manufactures questions raising up during the check of the CoAs prohibiting the distribution of the product in Russia
- Organizes the cooperation with other dpts/manufacture to get the regular input mandatory for the business. e.g. access to approved NDs; RU-GMP status of manufactures, cooperation with QPs from manufacturer
- Organizes the local control of the first 3 batches of a newly imported product and provides Rozdravnadzor with the results
- Responsible for archiving all relevant documentation according to company rules
- Permanent follow up and assessment of relevant local legislation and authorities practices to be shared with superiors and internal business partners
- Reports in time to Rozdravnadzor and company decisions to stop further production (timely limited or for ever)
- Submission of Quality test protocols for each imported product (API/strength/ formulation/manufacturer) distributed in the previous year as conducted by accredited Quality testing laboratories to Rozdravnadzor by Feburary 1st of the following calendar year latest.
- Conducting all actions related to random Q test of the marketed products
- Elaborates internal procedures in the framework of a Quality Mgmt system which ensures that compliance of processes with legal obligation and internal Menarini rules
- Conducts audits to contractual partners f.e. logistic providers to ensures fulfillment of contractual obligation related to the quality of the products
- Conducts self-inspections to departments with have relations to the distribution of the products
- Take action to improve professional skills by visiting training courses conducted by Menarini or external providers
- Propose actions to improve the quality mgmt. system and lead the implementation
- If Proposal for additional main duties/responsibilities is welcome I need to extend the main tasks
Education and Experience:
University degree in Pharmacy or Chemistry
Minimum 2-year experience in pharmaceutical business, preferable in QC
broad knowledge of RU pharmaceutical law
Skills
Fluent in English (written and spoken)
Very high degree of: flexibility, initiative, organizational, analytical and communication skills;
Team orientation;
Ability to work under pressure;
Willingness to act as an interface between local and HQ functions;
Strong IT skills in common PC applications;
Collegiality;
Ability to communicate effectively;
Self-confidence and ability to self-assess;
Drive to perform;
Откликнуться на эту вакансию: Qualified Person (Quality of medicinal products)
Предыдущая вакансия:
Вакансия № 10507352 на должность Менеджер по персоналу от компании ООО Старое Такси Москва в городе (населенном пункте) Москва