Quality Monitoring Lead Computer System Validation - Mechelen,BE
Core Purpose of Job:
The “Computer System Validation - Quality Monitoring Lead” is responsible providing continuous Computer System Validation (CSV) support during the Galapagos System Development Life Cycle Activities.
- Provide the necessary quality support during the “set-up, implementation, change control and decommissioning activities” of GLPG computer systems.
- Provide quality oversight and review / approve computer systems validation deliverables as required, incl. validation plans, requirement specification documents, validation protocols, test scripts, IQ/OQ/PQ validation reports and associated change control to ensure regulatory requirements are met.
- Act as the GLPG Computer System Validation SME supporting the Galapagos organisation.
- Contribute to the development / maintenance of the necessary procedural documents describing the computer system validation activities and ensure that the computer system related “change control mechanisms” are integrated in the GLPG Quality Management System.
- Collaborate with the Quality & Compliance Lead with regards to CSV audit programs by independent auditors. Assists the business stakeholders to ensure proper CAPA formulation.
- Build a collaborative working relationships with the IS department and cross-functional peers. Assists in driving change to build a culture of compliance throughout the organization.
- Masters degree in a scientific discipline or engineering
- Approximately 10 years experience in Computer System Validation
- Strong knowledge of Development processes within GXPs and regulatory requirements
- Good understanding of Quality Management Systems
The ability to present complex issues in a way that is understandable cross-functionally and at all levels of the organization, excellent problem solving, and analytical skills, including
knowledge of root cause analysis tools / methodologies
Strong interpersonal skills resulting in an effective (intra- and cross departmental) team player. A strong personality, a high degree of flexibility, assertiveness and excellent communication skills are essential to success. In addition, well-developed problem solving, decision-making and analytical thinking skills are highly desirable.
Good communication / interpersonal skills and diplomacy are essential to be successful in the Quality Monitoring role. Knowledge of the corporate structure, knowledge of the corporate culture and the organization of the external partners are essential.