- Maintains IT GxP systems' validated status
- Executes Change Control governance
- Acts as System Matter Expert
- Coordinates Yearly Reviews
- Manages validation projects
- Performs activities contributing to system validation
- Timely escalates problems in the approval process
- Degree in Life Sciences, Computer Science, or related fields
- Minimum 3 years' experience in regulated environment
- Good knowledge of GxP regulations and GDPR requirements
- Expertise in Computer System Validation for Pharmaceutical industry
- Strong Quality mindset
- Excellent communication skills
- Independent and reliable
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Computer System Validation Specialist - Barcelona, España - Centrient Pharmaceuticals Netherlands
Descripción
Centrient Pharmaceuticals is a leading manufacturer of beta-lactam antibiotics and a provider of next-generation statins and anti-fungals, producing and selling intermediates, active pharmaceutical ingredients, and finished dosage forms.
Committed to Quality, Reliability, and Sustainability, our 2200+ employees work tirelessly to meet customer needs and contribute to the fight against antimicrobial resistance.
Established 150 years ago as the 'Nederlandsche Gist- en Spiritusfabriek', formerly known as Gist Brocades, our company is headquartered in Rotterdam, with operations in China, India, Spain, the United States, and Mexico. Centrient Pharmaceuticals is owned by Bain Capital Private Equity.
The Position
Reporting to the IT Quality and Validation Manager, the CSV Specialist will maintain the validated status of global IT systems, such as SAP, TrackWise, Veeva, and EDMS, in compliance with regulations like GxP, SarbOx, CFR part 11, EU GMPs Annex 11, and GAMP. Responsibilities include defining IT Quality systems and validation methodology, coordinating validation activities, acting as a System Matter Expert on IT Quality, managing validation projects, and more.
Main Activities and Responsibilities
Requirements
Benefits
Terms and Reward
We offer a local contract in a challenging, comprehensive, operational environment with ample growth opportunities, open communication, and a flat organizational structure.
The Procedure
Please submit your application via the 'apply' button, including your CV & cover letter in English. Applications without these documents will not be considered. For more information, visit our website. Reference checks are part of the recruitment process.
