The role
0301- Plan, coordinate and execute Computer System Validation (CSV) activities within a GMP-regulated environment.
02- Support the validation lifecycle of GxP-relevant computerized systems, from initial requirements through implementation, validation and operation.
03- Prepare, review and maintain validation documentation, including Validation Plans, URS, Risk Assessments, Functional Specifications, Test Protocols and Traceability Matrices.
04- Support and/or execute IQ/OQ/PQ testing, User Acceptance Testing and other validation activities.
05- Ensure that computerized systems are validated in accordance with GMP, GxP and internal quality standards.
06- Perform risk-based assessments and support the definition of appropriate validation strategies.
07- Ensure compliance with Data Integrity and ALCOA+ principles throughout the system lifecycle.
08- Support the management and investigation of deviations, change controls and CAPAs related to computerized systems.
09- Review and approve CSV-related documentation from a Quality Assurance perspective.
10- Support the preparation for and participation in internal and external audits and regulatory inspections.
11- Collaborate closely with IT, Quality Assurance, Engineering, Manufacturing, Quality Control, Automation and System Owners.
12- Ensure that changes to computerized systems are assessed, documented and implemented in accordance with GMP and change control requirements.
13- Contribute to the continuous improvement of CSV processes, validation strategies and quality systems.
14- Support the development and implementation of SOPs, procedures, work instructions and validation standards.
15- Provide QA/CSV expertise during projects, system implementations, upgrades and remediation activities.
