Description
The Computerized System Validation Specialist will maintain and monitor the validation status of IT systems affecting Good Manufacturing Practices, prepare validation documentation, set up and maintain validation studies, assess changes requiring validation, and ensure compliance with GMP, GAMP 5, Annex 11, Part 11, and data-integrity requirements. The role works across the Sharp Heerenveen and Sharp Hamont sites, supports internal and external audits, and requires a relevant IT degree or HBO-level ability, several years of pharmaceutical production experience, GAMP 5 knowledge, and proficiency in English and Dutch.
