An opening for a Computer Systems Validation Engineer has come to market with a large multinational pharmaceutical company based in Denmark.
Preparation of Decommissioning/Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change control.
Manage, co-ordinate, develop and execute the validation deliverables for new Information System (IS) and current projects.
Support and co-ordinate the qualification, decommissioning and validation processes.
Responsible for ensuring that computerised systems are in full compliance with regulatory requirements, company policies and procedures.
Provide compliance leadership, direction, and execution in Computer System Validation for new and existing projects
Support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.) Participate in required project teams.
Responsible for ensuring that the Technical Development Manager is consulted on all validation deliverables.
Degree in Science/Engineering or related area
3 years' experience in a similar role
Knowledge of cleaning validation a distinct advantage
Experience in oral solid dose a distinct advantage
Must have experience in decommissioning of equipment & writing of protocols