Computer System Validation Specialist

hace 1 mes


Barcelona, Barcelona, España Centrient Pharmaceuticals A tiempo completo

Centrient Pharmaceuticals is a leading manufacturer of beta-lactam antibiotics and a provider of next-generation statins and anti-fungals.

We produce and sell intermediates, active pharmaceutical ingredients, and finished dosage forms.

We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines.

Our commitment to Quality, Reliability, and Sustainability drives everything we do, with over 2200 employees working continuously to meet our customers' needs.

We actively participate in the fight against antimicrobial resistance, working towards a sustainable future.

Founded 150 years ago as the Nederlandsche Gist- en Spiritusfabriek, our company was known as Gist Brocades.

Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States, and Mexico.

Centrient Pharmaceuticals is wholly owned by Bain Capital Private Equity, a leading global private investment firm.

The CSV Specialist will maintain the validated state of global IT systems according to applicable regulations, including GxP, SarbOx, cGMP, and EU GMPs Annex 11.

They will ensure the embedding of Quality and Validation in the total Centrient IT approach, thinking, and acting.

Key responsibilities include maintaining IT GxP systems in validated status, executing Change Control governance, acting as System Matter Expert on IT Quality and Validation, and managing validation projects.

The ideal candidate will have a degree in Life Sciences, Computer Science, or a related field, with a minimum of 3 years' experience with enterprise systems in a regulated environment.

They will have experience with Application Lifecycle Management Systems, be fluent in English, and have strong knowledge of GxP regulations, ideally in the field of computer system validation.

Additional requirements include good knowledge of cGxP and GDPR requirements, deep expertise in Computer System Validation for the Pharmaceutical industry, and knowledge in the IT and telecommunications domain.

We offer a local contract in a challenging, comprehensive, operational environment with many opportunities for personal input and growth.

The organization is very flat, with a lot of freedom and responsibility in an open, direct, and informal atmosphere.

We invite you to visit our website www.centrient.com for information about our company.



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