As Global Lead IT CSV Lead, you will act as the Subject Matter Expert (SME) and process owner for Computerized System Validation (CSV) within the IT/OT/Automation landscape. You will lead and support validation activities, contributing to project execution, compliance, and system quality. CSV Management and Validation Procedures:
Manage sub-elements of the Quality System Framework, specifically QSE 4.Share knowledge and provide training on CSV methods, processes, and systems.
Establish and manage CSV methods, processes, and systems.
Develop and implement corrective actions in response to audit findings.
Conduct assessments of computer systems, software applications, and processes.
Collaborate with cross-functional teams to create and maintain validation documentation.
Design and implement comprehensive test strategies.
Provide technical guidance and support to project teams.
Academic Master’s degree.
At least 5 years of experience in IT, automation, or QC computerized systems.
Strong understanding of computer systems, software applications, and validation processes.
Experience in developing and executing validation test plans, test scripts, and test cases.
Fluency in written and spoken English; Dutch language skills are a plus.
Critical evaluation and interpretation of data.
Strong knowledge of pharmaceutical manufacturing processes and quality systems.
Social skills such as tact, listening, service attitude, and persuasiveness.
Influence on the quality and efficiency of computerized systems.
Are you looking for a position at a flexible and fast-growing company with an exciting history? Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.
We also offer an attractive holiday system exceeding the legal holidays and homeworking after a successful onboarding (after 3 months).