от компании (организации): Abbott Laboratories в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Производство"
с заработной платой: по договоренности
Вакансия № 13853104 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Четверг, 12 сентября 2024 года.
Дата обновления вакансии № 13853104 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 № 13853104 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: GMP Auditor
The role of the Auditor function is:
- To manage on-site audits and Quality Questionnaires, related to Suppliers, Third Party Manufacturers & affiliates for GxP and Pharmacovigilance (PV) that fall under the responsibility of EPD QA (EPD Affiliate and Veropharm). The scope is Suppliers and Third Party Manufacturers that provide materials, services and products to Russia EPD. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers, service providers, 3PL providers and Third Party Manufacturers who provide intermediate/final products to Russia EPD (EPD Affiliate and Veropharm).
- To manage internal audits (self-inspections) for Veropharm manufacturing sites and commercial affiliates (EPD and Veropharm)
- To perform regular Regulatory update to be sure that current GxP and licensing requirements are known, and shared on the regular base.
- To maintain the system for insuring of External Inspections and AQR audits readiness of Veropharm manufacturing sites and commercial affiliates (EPD and Veropharm)
Key Responsibilities:
- Manage on site GMP/GDP, ISO 9001, IS 13485, ISO 17021 audits for regional and local Suppliers and Third Party Manufacturers and affiliates.
- All activities required to plan, prepare for, conduct, report and close the assigned audits.
- Ensure that all audit related information is documented into the Audit Tracking system in a timely manner.
- Manage Quality Questionnaire for Suppliers, affiliates and Third Party Manufacturers regionally
- Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close for affiliates, regional supplier and TPMs.
- Timely information on the audits to management and stakeholders.
- Escalation of any critical findings or negative audit outcomes to regional EPD senior management, in line with the applicable policy and procedures.
- Reviewing any Quality Questionnaires returned by the Suppliers/TPMs and resolving any issues.
- Read and extract developing regulations and trends from available sources to provide recent perspectives during audits.
- Ensure a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.
- Responsible for supporting creation and implementation of continuous improvement initiatives.
- Actively participates on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations
- Provide support to regional EPD plants, affiliates and Contract Operations QA in the timely resolution of issues related to Suppliers and Third Party Manufacturers.
- Discuss with and agree with the affiliates, Suppliers and TPMs a timely implementation of corrective and preventive actions, as needed to prevent recurrence.
- To participate in internal audits (self-inspections) for Veropharm manufacturing sites and commercial affiliates (EPD and Veropharm)
- To take part in the preparation to external and AQR audits of Veropharm manufacturing sites and commercial affiliates (EPD and Veropharm).
Education:
University (high) education at a relevant scientific discipline or other technical/scientific, or industry experience with sufficient exposure to pharmaceutical or related industries
ISO Certified Quality Auditor (CQA) Certified Quality Engineer (CQE), or other international certification are desirable.
Experience:
At least 5 years in the Pharmaceutical Industry and/or related industries; and at least 3 years of GXP and\or ISO Auditing experience
Background:
- Knowledge and understanding of the relevant GxP, PICs, ICH, WHO and other relevant technical guidelines, Russian legislation
- Ability to communicate, understand and mentor individuals in highly specialized technical fields.
- Project Management and troubleshooting skills
- Advanced written and verbal skills in Business English
- Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives.
Other requirements include:
- Ability to use Quality Tools such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact base decisions making.
- Willingness to travel
- Strong communication and negotiation skills
Percentage travel: at least 50%
Откликнуться на эту вакансию: GMP Auditor
Предыдущая вакансия:
Вакансия № 13853103 на должность Оператор-наладчик от компании ООО РусВахта в городе (населенном пункте) Шатурторф