Quito Qualification & GEP Manager

Job description

1d9a1869/2420a2c9-58f0-404e-9903-b.jpg 1d9a1869/3609b7ac-0cd2-4d70-a6a9-9.jpg 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. Paola Vasquez López 1d9a1869/e1cd1d28-63ac-40f0-9f9d-3.jpg