Grünenthal Group
Grünenthal Group
Grünenthal Group एक विज्ञान-आधारित दवा कंपनी है, जो दर्द प्रबंधन और उससे संबंधित रोगों पर केंद्रित है। जर्मनी के आकेन में मुख्यालय वाली यह कंपनी दर्द से जूझ रहे लोगों के उपचार को बेहतर बनाने के लिए दवाएं और स्वास्थ्य सेवा प्रौद्योगिकियां विकसित करती है। इसका संचालन लगभग 100 देशों में फैला है और अनुसंधान, विकास, विनिर्माण तथा वाणिज्यिक टीमों में लगभग 4,400 कर्मचारी कार्यरत हैं। 1946 में स्थापित Grünenthal एकीकृत दवा मॉडल को दर्द से मुक्त दुनिया बनाने की दीर्घकालिक महत्वाकांक्षा के साथ जोड़ती है।

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.

विवरण

  • 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.

आवश्यकताएँ

  • 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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