Вакансия № 801352 на Электронной Службе Занятости Населения от компании АНКОР Медицина и фармация на должность Senior Quality Assurance Specialist / Associate Director EQA в населенном пункте Москва

☑ Основы вакансии:

Опыт работы: 3–6 лет.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Российская Федерация, Москва.

☑ Актуальность объявления:

Это объявление № 801352 добавлено в базу данных: Воскресенье, 7 апреля 2024 года.

Дата его обновления на этом интернет-ресурсе: Суббота, 20 апреля 2024 года.

☑ Репутация компании "АНКОР Медицина и фармация":

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☑ Подробности о вакантном месте:

Large foreign pharmaceutical company is looking for Quality Manager / Associate Director EQA

Responsibilities:

• Evaluate and/or release products to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records.
• Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer.
• Provide support for audits of EP/ExP and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted.
• Oversee repackaging activities in the ExP/EP.
• Conduct routine analytical change requests and support process modification change controls.
• Stability Program management, including review of stability reports, and Annual Product Review assembly.
• Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.
• Track and monitor operational and quality performance of the external manufacturer/partner.
• Assist the maintenance of retention samples; responsible for shipment under quarantine.
• Support routine process validation; review and approve validation reports/tech transfer.
• Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes.
• Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.

Requirements:

• BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
• Minimum of 3 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance.
• English upper- intermediate.
• Ability to travel.

☑ О компании:

Логотип (эмблема, торговая марка, бренд) компании:

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