от компании (организации): ANCOR Consumer Goods в городе (населённом пункте): Москва, Россия
в отрасли экономики "Производство, сельское хозяйство" → "Фармацевтическая промышленность"
с заработной платой: по договоренности
Вакансия № 15527155 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Среда, 16 октября 2024 года.
Дата обновления вакансии № 15527155 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 № 15527155 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 Unit Lead
A competition for the Quality Unit Lead position is open in a foreign biopharmaceutical company
Responsibilities:
- Ensuring that a Quality Management System is implemented and maintained including the local market:
- Acting as the local Qualified Person responsible for GMP & GDP in accordance with Market regulatory requirements
- Responsible for GMP activities for certification of Manufacturing sites
- Being a conduit between local Health Authority and/or Trade and Industry Association and the corresponding Company Global functions for GMP documentation coordination, GMP applications and filing
- Attending Health Authority inspections of Manufacturing sites as the In-market quality subject matter expert
- Facilitating the CAPA responses
- Ownership of implementation of new GMP/GDP Eurasian requirements
- Maintaining Quality System Documentation: procedures and records
- Company Policy/Directives/SOPs impact assessment and implementation
- GDP and Local regulations impact assessment and implementation
- Meeting the requirements of the defined Quality Unit activities
- Ensuring initial and continuous GMP/GDP training programs are implemented and maintained, including product identification and avoidance of falsified
- Developing and maintaining locally the Quality Manual
- Ensuring that relevant customer complaints are dealt with effectively
- Performing periodic Self-inspections according with the self-inspection plan and puts in place necessary corrective measures
- Ensuring implementation of Deviation and CAPA management
- Ensuring implementation of the Change Control management
- Reviewing the APQRs, as required per local regulations
- Leading the Quality Management Review/Quality Council of the Market
- Reporting quality metrics and implements adequate action plans for metrics achievement when necessary
- Participation in periodic local Senior Management / Leadership team review meetings
- Ensuring implementation of following Quality Operations:
- Suppliers management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status
- Customers oversight: periodic customer License verification
- Production Quality status and batch release or approval to the market
- Local QC testing, CoA review and local release, when applicable
- Analytical transfer coordination/approval to meet product launch, when applicable
- Handling compliance/quality issues with the impacted market team
- Attending the Market Action meetings when required and defines the adequate action plans within market
- Ensuring On Hold products request are observed
- Coordinating and promptly performing any market action operation, recall, for medicinal products. Mock recalls
- Deciding on the final disposition of rejected, recalled or falsified products
- Approval of the returns to saleable stock, according to Company requirements
- Support Supply Chain to avoid Back Orders
- Providing quality input on shortage situations and oversight reporting to Health Authority
- Medical samples Quality distribution oversight
- Supporting of sampling requested by HA (product, procedures, reference substances)
- Keeping appropriate records of any delegated duties
- Facilitating that Company requirements are implemented in the Local Distribution Centre for:
- Warehousing facilities
- Secondary packaging facilities
- Transportation processes
- Quality Risk Management:
- Coordination and preparation of Quality Risk Management
- Participate in the periodic Business Review with the DC
- Inspections and Regulatory Surveillance:
- Maintenance of the Wholesale Distributor License with Regulatory agency
- Import certificates, when requested
- Support the Global Quality Audits in the market
- Preparation of HA inspection in local entity and leading HA inspection
- Anticipation the new directives (Regulatory surveillance) and proactively drive change
Requirements:
- Minimum Bachelor of Science (preferably - pharmaceutical, biological, chemical or similar)
- Experience within the quality function of the pharmaceutical health care industry or with regulatory agencies
- Experience in Quality Operations
- Manufacturing facility experience, Proficient in GMPs
- Experience working with Health authorities
- Managerial and Operational skillset
- Experience in biological products, commercial products, sterile products, Distribution practice, Batch release
- People management skills
- High communication and interaction skills, familiar with local culture
- Good verbal, written and presentation skills in English
Откликнуться на эту вакансию: Quality Unit Lead
Предыдущая вакансия:
Вакансия № 15527133 на должность Продакт-менеджер (серверного оборудования и СХД) от компании ДОЛОМАНТ в городе (населенном пункте) Москва