от компании (организации): Abbott Laboratories в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Регистратура"
с заработной платой: по договоренности
Вакансия № 6789011 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Четверг, 25 июля 2024 года.
Дата обновления вакансии № 6789011 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 22 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 6789011 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: Development and Technical Support Manager (Quality Affairs, Pharma)
REPORTS TO: Regional QA Director
DEPARTMENT: Quality Assurance
Primary Function/Primary Goals/Objectives
The QA Manager, Technical Support primary responsibility will include:
- Managing product and process quality and compliance throughout the life cycle from development to commercialization
- Guarantee the quality and compliance of the product and process during identification of the commercial manufacturing site and all the technology transfers and improvements.
- Guarantee the quality and compliance of product and process pre-commercialisation during development and clinical trials
- Provide expert support to facilitate issue resolution for key investigation and compliance issues
Key Responsibilities:
Reporting to the Head of QA Russia, key responsibilities will include:
- Ensures development / continuous improvement and implementation of GxP, PV and EPD QA requirements.
- Responsible for ensuring that all the quality activities during technology transfer and development are timely completed meeting the business needs of the division and the Authorities and Corporate Quality Standards.
- Implementation and maintenance of QMS for I&D and MS&T in Russian region.
- Serve as technical resource of Russia EPD Quality organization during process and regulatory deficiency issues, risk assessment target cost initiatives and other continues improvement initiatives
- Supporting the lifecycle management strategy and supporting its operational execution as member of the workstream team or equivalent cross-functional team.
- Support the quality aspects of the Product Portfolio Expansion Initiatives and other Non-Centrally Supported Products
- Key Quality contact during CMC activities including specification setting
- QA project coordinator for products development and implementation projects
- Subject matter expert for API supplier audit
- Approver of stability programs and Technical Transfers Protocols
Education:
- Bachelor’s Degree or equivalent in life science
Background:
- At least 5 years pharmaceutical experience in the fields of pharmacovigilance, quality assurance or regulatory affairs
- At least 5 years of combined experience in QA, Operation, RA or Technical Function in Pharmaceutical environment
- Expertise with regards to relevant PV/GCP/GLP/GMP regulatory requirements
- Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations.
- Extensive Knowledge of international and local quality system and compliance legislations and standards.
- Troubleshooting and issues resolution skills
- Project management expertise
- Perceptual and analytical problem solving related to: removal of obstacles, setting priorities, people, resources and facilities involvement.
- Ability to communicate affectively, both orally and in writing for both technical and non-technical audience. Including National and International Health Authorities
- Teamwork attitude and capability of understanding and overcoming different cultural and language obstacles to provide solutions satisfying corporate, divisional and local objectives.
- Ability to use Quality Risk Assessment and Root Cause Analysis tools
- Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
- Detailed knowledge of inspection and auditing standards
- Extensive knowledge of PV and GxP regulatory requirements and industry best practices.
- Flexibility to adapt to changing assignments and ability to effectively prioritize.
- Project management, interpersonal, and communication skills and ability to work independently and as part of a team.
Accountability/Scope:
The QA manager reports to the Head of QA Russia
Supervisory/Management Responsibilities:
QA Development Manger – Volginsky manufacturing site
QA Development Manger – Belgorod manufacturing site
QA Development Specialist – Moscow
and mentoring of specialists in manufacturing site organizations.
Percentage travel: at least 30%
Откликнуться на эту вакансию: Development and Technical Support Manager (Quality Affairs, Pharma)
Предыдущая вакансия:
Вакансия № 6788994 на должность Столяр-модельщик от компании ООО MOON (Группа Компаний) в городе (населенном пункте) Мытищи