от компании (организации): GlaxoSmithKline Consumer Healthcare в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Производство"
с заработной платой: по договоренности
Вакансия № 13185579 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Пятница, 20 сентября 2024 года.
Дата обновления вакансии № 13185579 на сайте Работа в Москве и Московской области (МО, Подмосковье): Пятница, 15 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 13185579 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: EEU Quality Project Manager
Job Purpose:
• Ensure Eurasian Economic Union (EEU) GMP and GDP requirements for are embedded into all processes carried out across the Local Businesses ensuring as well that they are in compliance with GSK standards and policies, Guide for Commercial Companies, GMP, GDP and regulatory requirements.
• Ensure manufacturing sites within GSK CH supply network are updated on EEU regulations and follow relevant implementation plans
• Ensure local regulatory submission activities are properly supported by Quality network
• Will actively manage and have oversight responsibilities for implementation of EEU regulations across Local Businesses
Temporary project for 1 year.
Key responsibilities:
Ensure LOC Quality processes and systems are in place for all activities mandated by EEU GMP/GDP regulations and carried out across the Local Business ensuring as well that they are in compliance with GSK standards and policies, Guide for Commercial Companies. These processes and systems would related (but not limited) to:
- GMP inspections. Identify and implement EEU GMP requirements to manufacturing sites across GSK supply network:
- Accountable for review EEU GMP regulations, practices and known observations against EU GMP requirements
- Communicate EEU GDP requirements to manufacturing sites and support with regulatory insight to ways of implementing
- Develop and align GMP inspection plan with sites and other stakeholders
- Execute GMP inspection plan in terms of submission of applications for inspection and keep communication with Authorities for related topics
- In case of inspections within contracted period get regulatory insight to found observations and support site with CAPA
- Participate in external industry meetings and share trends in inspection practice within Quality network
- GDP. Identify and integrate EEU requirements specific for product distribution to local processes:
- Accountable for on-time review of all applicable existing and drafted EEU regulations.
- Ensure stakeholders across markets are timely informed of regulations and impact
- Liaison within LOC Quality organizations ways of following EEU requirements.
- Ensure that local procedures are aligned with EEU regulations
Qualification:
• Minimum of 2 years experience within the Pharmaceutical Industries in quality
• Knowledge of regulatory requirements pertaining to GMP/GDP.
• understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents and performing audits
• Knowledge on effective quality documentation systems
• Professional written and verbal communication skills. Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization
• Ability to influence and motivate stakeholders at any level of the LOC organization
• Analytical mind, good attention to detail and problem solving skills within a structured process
• Good team player – works well in cross-functional teams
• Good time management skills, with ability to multi-task and work under pressure
• Strong interpersonal and negotiation skills
• Concise and persuasive in the description of the different QA situations. Able to stick to the standard and not be pressurized.
• Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods
• Flexible thinking – able to challenge and see views from different perspectives
• Ability to self-motivate and be resilient and focused under pressure
• Able to work effectively in English
• Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
Откликнуться на эту вакансию: EEU Quality Project Manager
Предыдущая вакансия:
Вакансия № 13185578 на должность Повар холодного цеха от компании ООО JUST FOR YOU в городе (населенном пункте) Москва