Qualification & GEP Manager

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Qualification & GEP Manager

Country

Ecuador

City

Quito

Department

Global Operations & Production

Job ID

45493

​Management | Permanent | Full-time | On-Site​

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.

What the job looks like

Each day you'll enjoy a variety of challenges, such as:

• Leading commissioning, qualification (IQ/OQ/PQ), and requalification activities for GMP equipment, systems, and utilities.
• Managing the calibration master program to ensure metrological traceability and regulatory compliance.
• Driving compliance with GMP, GEP, ISPE, and validation requirements.
• Participating in CAPEX projects, FAT, SAT, and equipment start-up activities.
• Leading deviation investigations, CAPAs, and change control processes.
• Collaborating cross-functionally to maintain the validated state of critical assets and utilities.

What you'll bring to the table

To make the most of this role and truly thrive, you should have:

• A degree in Mechanical, Electromechanical, Industrial, Chemical Engineering, or a related field.
• At least 5 years of experience leading qualification, commissioning, calibration, and GMP compliance activities.
• Strong knowledge of GMP, GEP, ISPE, ASTM E2500, validation, metrology, risk management, and pharmaceutical utilities.
• Experience working with HVAC systems, purified water systems, and SAP PM.
• Proven leadership, decision-making, communication, and cross-functional influence skills.

______________________________________

Robert Pabón Castillo, the Hiring Manager

About Grünenthal

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focussing all of our activities and efforts on working towards our vision of a world free of pain.

Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2024, Grünenthal employed around 4,300 people and achieved sales of € 1.8 billion.

Your HR contact

Paola Vasquez López

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Meet our teams

Website: www.grunenthal.com

LinkedIn: Grunenthal Group

Instagram: @grunenthal

Meet our teams

Website

www.grunenthal.com/

LinkedIn

Grunenthal Group

Instagram

@grunenthal

Apply now »

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