- To assure that all Computer Systems Validation related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) of computerized systems.
- Act as Process Owner for Computer Systems Validation management
- Review and approve CSV documents such as SOPs, user requirements, impact/risks analysis’s, Validation Plans, tests, changes, deviations etc…) in order to maintain compliance to regulations, guidelines, J&J policies and standards.
- Maintain a current knowledge of international regulations, guidelines and new evolutions related to CSV through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve Computer Systems Validation at Janssen.
- Prepare for computer system audits and inspections.
- Be the spokesperson for CSV related matters during audits and inspections.
- Perform and follow up on internal and external audits to accomplish regulatory compliance.
- Be part of engineering & IT teams and interact with other groups for the introduction of new systems and processes. To give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects. Be a member of cross-functional teams to realize cross-departmental objectives
A. Education and/or additional training:
- 5 plus years of comprehensive experience in Computer System Validation required
- Strong working experience in regulatory CSV compliance (21 CFR Parts 11, 210, 211; EU Directive 2003/94/EC and annex 11; GAMP) required
- Strong working experience in Process control and IT systems used within a pharmaceutical/API environment (such as PLCs, warehouse management systems, environmental monitoring systems, incident handling systems, change request systems, document management systems, training systems, LIMS systems, ERP systems,...) required
- Demonstrated experience in writing and managing compliance documentation including the ability to coach others for the quality of content
- Excellent verbal and written communication skills required. Fluent in Dutch & English (written and spoken)
- Possess the credibility and experience to act as subject matter expert during internal audits and external regulatory inspections.
- Experience and understanding of audit readiness and management required
- Demonstrated ability to manage QA aspects within complex projects, priorities and multiple tasks
- Strong influencing and negotiation skills
- Strong collaboration and teaming skills
- QA experience preferred
Janssen Pharmaceutica N.V. (7555)