Description:
* Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities for mainly small scale equipment. 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 validation 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 Validated 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.
* Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for systems in scope.
* Responsible for the validation documentation through approval and implementation.
* Provides input in review/assessment of changes to as whether they impact the validated 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).