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Centrient Pharmaceuticals Netherlands is seeking a highly skilled Computer System Validation Specialist to join our team. As a key member of our IT Quality Assurance department, you will be responsible for maintaining the validated state of our global IT systems, ensuring compliance with regulatory requirements, and promoting a culture of quality and continuous improvement.
Main Responsibilities- Validation and Compliance: Maintain the validated state of IT systems, including SAP, TrackWise, Veeva, and EDMS, in accordance with GxP, SarbOx, cGMP, and EU GMPs Annex 11 regulations.
- Quality Oversight: Embed quality and validation into our IT approach, coach and train colleagues, and ensure compliance with Centrient policies and ISOPs.
- Change Control Governance: Execute change control governance in line with processes and stakeholders, ensuring timely issuance of validation documents.
- System Matter Expert: Act as a subject matter expert on IT Quality and Validation, providing guidance and support to the team.
- Validation Projects: Manage validation projects, including coordinating validation activities, ensuring timely issuance of validation documents, and performing activities that contribute to the validated state of systems.
- Education: Degree in Life Sciences, Computer Science, or related fields.
- Experience: Minimum of 3 years' experience with enterprise systems in a regulated environment.
- Skills: Strong knowledge of GxP regulations, cGxP, and GDPR requirements; deep expertise in Computer System Validation for the Pharmaceutical industry; knowledge in the IT and telecommunications domain; strong quality and continuous improvement mindset; strong communications skills.
Centrient Pharmaceuticals Netherlands is a leading manufacturer of beta-lactam antibiotics and a provider of next-generation statins and anti-fungals. We are committed to quality, reliability, and sustainability, and our team of over 2200 employees works tirelessly to meet our customers' needs. We are proud to be a part of the fight against antimicrobial resistance and are committed to a sustainable future.