от компании (организации): GSK в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Сертификация"
с заработной платой: по договоренности
Вакансия № 19383948 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Вторник, 29 октября 2024 года.
Дата обновления вакансии № 19383948 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 № 19383948 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
более 6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Quality and Risk Management Manager
We are looking for Quality and Risk Management Manager who will add value to business by providing quality and risk management implementation and maintenance on the LOC level and EEU region, ensuring the support for the following processes: risk management process, written standards management, self-inspections, CAPAs management, GAP analysis process; audits support.
Key Responsibilities
- Works in close collaboration with the MENA-CIS Area Regulatory Hub to implement QRM key global processes at the LOC level and region (EEU – Eurasian Economic Union) if required;
- Active participation in the risk management process, including identification potential issues and risks related to the artworks; to keep timely updated the risks register with RA risks;
- Oversees and actively support WSs update process with global procedures/ policies, to keep updated the RA SOP matrix, lead artwork WS update process with global procedures / policies;
- Oversees and actively support L1 audit process, to keep updated the L1 audit schedule, to have control over timely update of the self-inspections findings tracking (if applicable), to have control over timely reports providing by the Lead inspectors. Participate in Independent Business Monitoring (IBM) and Audit and Assurance (A&A) processes, L2 audit;
- Oversees and actively support CAPAs management process, to have control over the timely CAPA development and providing by owners, to have control over the timely update of the CAPA register;
- Oversees and actively support GAP analysis process, to have control over the timely GAP analysis providing for new global procedures / policies;
- Support the program of the regulatory professional development;
- Manage AW process, including the development, revision (if applicable) and approval of artworks in the appropriate system, artworks double check to ensure the compliance between artworks and packaging of the products, marketed by GSK in Russia and Armenia with the GMS requirements, local / regional regulation(-s) and with registered regulatory details;
- Participate in L1 in accordance with the timelines;
- Participate in appropriate trainings for improvement of professional knowledge and skills.
Requirements:
- Graduate in pharmacy/biology/chemistry with considerable experience in Quality/ Regulatory Affairs with managerial responsibilities;
- Basic knowledge of drug development process, of manufacturing, logistics and distribution processes; knowledge of the regulatory authorities structure and processes of registration
- Insightful and forward thinking, ability to recognize, anticipate and discuss potential regulatory challenges;
- Fluent written and speaking English;
- Ability to read, analyze and interpret complex regulatory documents and to respond effectively to sensitive inquires or complaints;
- Ability to work within diverse cultures and lead multifunctional matrix teams is beneficial;
- Experience in people management; team-building and team-working skills;
- Strong management and project leadership skills;
- Demonstrated ability to make decisions / influence outcomes that include assessment of the potential global impact;
- Analytical in thought process, multi task orientated; demonstrates attention to detail;
- Ability to influence and manage conflicts;
- Discipline; ability to organize the activities within the granted autonomy and to make rational use of working time.
What we can offer:
- Competitive salary
- Medical insurance, life insurance
- Meal allowance
- Mobile compensation
- Internal and external educational courses and trainings
- Professional and career development opportunities
- Corporate car/ car allowance
Откликнуться на эту вакансию: Quality and Risk Management Manager
Предыдущая вакансия:
Вакансия № 19383919 на должность Помощник менеджера WEB-проектов от компании ООО ЭМПИС в городе (населенном пункте) Москва