Qualification and Validation Engineer

Description:

• Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities for small scale equipment, including the related software. Develops, implements and executes validation studies for cGMP-critical process systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this.
• Performs qualification of systems in scope for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP's and Sanofi Procedures.
• Ensures that the qualified status of systems in scope is in compliance with cGMP at all times.
• Ensures projects are supported in conjunction with all required Sanofi and cGMP regulatory standards.
• Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provides technical assistance on current US FDA and EU validation requirements.
• Responsible for the validation documentation through approval and implementation.
• Provides input in review/assessment of changes to as whether they impact the qualified status and validation documentation, as appropriate.

Skills

• Knowledge of CGMP requirements in a regulated environment.
• Understanding of relevant quality and compliance regulations.
• Capable of troubleshooting validation issues.
• Good knowledge of quality management systems
• Experience: 2-4 years experience working in a Healthcare manufacturing environment, with experience in qualification of small scale equipment (including the related software).