Requirements: English
Company: Arcadis
Region: Geel , Flanders
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 , cGLPs 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).
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