Grünenthal Group
Grünenthal Group
Grünenthal Group — ауырсынуды басқару және соған байланысты ауруларға бағытталған, ғылымға негізделген фармацевтикалық компания. Штаб-пәтері Германияның Ахен қаласында орналасқан компания ауырсынумен өмір сүретін адамдардың емделу нәтижелерін жақсартуға арналған дәрі-дәрмектер мен денсаулық сақтау технологияларын әзірлейді. Компания шамамен 100 елде жұмыс істеп, зерттеу, әзірлеу, өндіріс және коммерциялық бағыттарда шамамен 4 400 қызметкерді біріктіреді. 1946 жылы құрылған Grünenthal интеграцияланған фармацевтикалық моделін ауырсынуы аз әлем құруға бағытталған ұзақ мерзімді мақсатымен ұштастырады.

Engineering Manager, GMP Compliance - Grunenthal Group, Quito Onsite

Lead GMP qualification, calibration, validation, and compliance activities for Grunenthal Group’s pharmaceutical manufacturing operations in Quito. Oversee CAPEX projects, investigations, change controls, and critical utility assets.

Сипаттама

  • Lead commissioning, qualification (IQ/OQ/PQ), and requalification for GMP equipment, systems, and utilities.
  • Oversee the calibration master program to maintain metrological traceability and regulatory compliance.
  • Ensure adherence to GMP, GEP, ISPE, and validation standards.
  • Support CAPEX projects, FAT, SAT, and equipment start-up activities.
  • Manage deviation investigations, CAPAs, and change control processes.
  • Work across functions to preserve the validated state of critical assets and utilities.

Талаптар

  • Bachelor’s degree in Mechanical, Electromechanical, Industrial, Chemical Engineering, or a related discipline.
  • Five or more years of experience leading qualification, commissioning, calibration, and GMP compliance work.
  • Strong understanding of GMP, GEP, ISPE, ASTM E2500, validation, metrology, risk management, and pharmaceutical utilities.
  • Experience with HVAC systems, purified water systems, and SAP PM.
  • Demonstrated leadership, sound judgment, clear communication, and cross-functional influence.

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