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Open nowPosted 18 days ago

Специалист по квалификации и валидации

ООО "ОКТАФАРМА-ФАРМИМЭКС"

Where
Рязанская область, Russia
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Your applicationOpen nowСпециалист по квалификации и валидацииООО "ОКТАФАРМА-ФАРМИМЭКС" · Рязанская область, Russia

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  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

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The clock on this job

Early applications get read.

11.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.4%3 days
  3. 11.8%7 days
  4. 18.6%14 days
  5. 35.6%30 days
  6. 45.1%60 days
This job: posted 18 days ago

The posting

Разработка и внедрение процедур по квалификации (валидации) производственных систем (чистые помещения, чистые среды, оборудование, компьютеризированные системы и пр.) и процессов в соответствии с требованиями GMP; Разработка стратегии (подходы) к проведению квалификации (валидации); Проведение оценки влияния (SIA) и анализ рисков (FMEA) с целью определения объектов квалификации (валидации) и объема их тестирования; Разработка квалификационных (валидационных) документов: URS, планы, протоколы, отчеты; Планирование и выполнение квалификационнхе (валидационных) испытаний: DQ, IQ, OQ, PQ; Участие в ходе выполнения мероприятий в рамках FAT и SAT, включая проверку документации; Осуществление мониторинга GxP-объектов, прошедших валидацию (квалификацию); Проведение оценки влияния изменений на статус квалификации (валидации) GxP- объектов; Проведение оценки значимости выявленных отклонений при проведении квалификационных (валидационных) испытаний и организация их расследования.

Высшее образование (фармацевтическое, химическое, биотехнологическое, техническое); Опыт работы на фармацевтическом производстве и/или в области квалификации (валидации) не менее 2 лет; Владение устным и письменным английским языком не ниже уровня Intermediate / Pre-intermediate; Умение работать в программах MS Office (Word, Excel, PowerPoint); Знание методик проведения квалификационных (валидационных) испытаний и основных методов статистического анализа; Навыки обращения с контрольно-измерительным оборудованием; Знание требований надлежащей производственной практики GMP (РФ, ЕАЭС, ЕС), отраслевых методических и руководящих документов (ICH, ISPE, PDA, PIC/S и пр.) в области квалификации (валидации). Ответственность, ориентация на результат, коммуникабельность, работа в команде, внимание к деталям.

Оплата занятий спортом,Добровольное медицинское страхование

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