Computer System Validation Professional

hace 3 días


Barcelona, Barcelona, España Centrient Pharmaceuticals A tiempo completo

At Centrient Pharmaceuticals, we're shaping the future of healthcare by developing essential medicines. As a leading manufacturer of beta-lactam antibiotics and provider of next-generation statins and anti-fungals, we strive for quality, reliability, and sustainability in everything we do.

We have over 2,200 employees working across our global network, with production facilities and sales offices in China, India, the Netherlands, Spain, the United States, and Mexico. Our company has a rich history, dating back 150 years to its founding as the 'Nederlandsche Gist- en Spiritusfabriek'. Today, we're wholly owned by Bain Capital Private Equity, a leading global private investment firm.

The Global Quality department is seeking a skilled Computer System Validation Specialist to join their team in Barcelona. This role will be responsible for maintaining the validated state of global IT systems, ensuring compliance with regulations such as cGMP, EU GMPs Annex 11, and GAMP. The ideal candidate will possess experience with enterprise systems in a regulated environment, specifically SAP implementation and validation.

The successful candidate will define IT quality systems and validation methodologies, coordinate quality oversight of IT activities, and monitor IT risks. They will also act as a system matter expert on IT quality and validation, manage validation projects, and perform activities that contribute to the validated state of systems. This includes change control, testing, organizing test sessions, investigations, preparation and execution of validation protocols and reports, and timely escalating problems in the approval process.

Key requirements include a degree in Life Sciences, Computer Science, or a related field, with a minimum of three years' experience in a regulated environment. Fluency in English is essential, along with strong knowledge of GxP regulations and cGxP requirements. Experience with Application Lifecycle Management Systems and deep expertise in computer system validation for the pharmaceutical industry are desirable.

As a valued member of our team, you'll enjoy a local contract, comprehensive benefits, and opportunities for growth and development in a challenging and dynamic environment. With a flat organizational structure, you'll have the freedom to take ownership and responsibility, while contributing to our mission of delivering high-quality medicines to those who need them most.

In return for your expertise and dedication, we offer a competitive salary of €70,000 - €90,000 per annum, depending on your level of experience and qualifications. If you're passionate about quality, technology, and the pharmaceutical industry, we encourage you to apply for this exciting opportunity.



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