Jobs / other
Sr. Computerized System Validation Specialist
Abbott · Weesp
What you will do
You are the SME for CSV, Data Integrity and GMP compliance;
You lead complex validation and implementation projects;
You develop CSV standards, governance and procedures;
You translate new regulations such as NIS2, Annex 11 and CSA into the organization;
You coach colleagues and advise management and project owners;
You actively contribute to the future CSV strategy for the Olst and Weesp sites (OneNL).
What you will do
Prepare, review and effectively coordinate validation documentation
Handle deviations, exceptions and CAPAs
Support audits and inspections
Ensure continuous availability of up-to-date information, reports and evaluations regarding Computer System Validation
Collaborate with QA, Operations, Engineering and IT
Ensure compliant lifecycle management of computerized systems
Act as the CSV project SME for projects involving automation aspects.
About the company
Manufacturing Automation consists of Application Managers, Automation Engineers and MES Designers and supports production, laboratories, facilities and utilities. The department forms the bridge between technology, compliance and the production departments.