Global Labware LIMS Manager

Overview

The company :

We are a partnered with a Global Pharmaceutical company who work with APIs, finished dosage forms, and branded pharmaceuticals, for both human and animal health. The company manufacture products for 100 countries, and their mission is to provide greater access to high need medicines across the globe. They have 18 state of the art facilities, located in more than 50 countries. This is for one of their mainstay sites, based in the heart of Madrid, they seek an experienced Quality manager with an IT background / skill set to help develop and implement their new QMS.

Role Overview

This role sits in the Global Quality Systems team, and will play a major role in one of the companies most important projects. The role intends to develop, then roll out and implement their new Quality Management System. You have the opportunity to lead an experienced team, then grow and develop this in the long-run!

Responsibilities

• Lead and manage new LabWare LIMS implementations.
• Manage LabWare LIMS and other enterprise systems (e.g., ERP, ELN, CDS, QMS)
• Leadership of a global team that cover CSV and Quality digital systems.
• Define and drive digital strategy for Quality systems.
• Full oversight of computerized system validation activities.
• Maintaining compliance with relevant regulatory standards, inc, FDA.
• Act as SME during regulatory Audits and local inspections.
• Collaborate with IT, Quality Operations, and Regulatory Affairs to ensure system alignment
• Proactively identify risks and drive corrective and preventive actions (CAPAs)

Qualifications

Benefits

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