Computer System Validation Specialist
hace 1 mes
Job Summary
Centrient Pharmaceuticals, a leading manufacturer of beta-lactam antibiotics, is seeking a skilled Computer System Validation Specialist to maintain the validated state of global IT systems. The ideal candidate will have a strong background in Life Sciences, Computer Science, or related fields, with a minimum of 3 years' experience in enterprise systems in a regulated environment.
Main Responsibilities
- Maintain IT GxP systems in validated status by coordinating validation activities and ensuring timely issuance of validation documents.
- Execute Change Control governance in line with processes and stakeholders like QA, Finance, etc.
- Act as System Matter Expert on IT Quality and Validation.
- Coordinate the Yearly Reviews on validated/qualified systems.
- Manage validation projects.
Requirements
- Degree in Life Sciences, Computer Science, or related fields.
- Minimum of 3 years' experience with enterprise systems in a regulated environment.
- Experience with Application Lifecycle Management Systems is desirable.
- Fluent in English language (written and spoken).
- Strong knowledge of GxP regulations, ideally in the field of computer system validation.
- Good knowledge of cGxP and GDPR requirements.
- Deep expertise in Computer System Validation for the Pharmaceutical industry.
- Knowledge in the IT and telecommunications domain.
About Centrient Pharmaceuticals
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. Our commitment to Quality, Reliability, and Sustainability is at the heart of everything we do.
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