Mes Validation Specialist (Dutch Speaker) Belgium, Europe J012430

Life Sciences, Belgium

A multinational pharmaceutical organisation requires an experienced MES CSV Specialist to join their Biotech manufacturing facility in Belgium.

Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities. Develops, implements and executes validation studies for cGMP-critical computerized systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this.
Performs validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP’s and Organisation Procedures.
Ensures that the Validated Status of computerized systems is in compliance with cGMP at all times.
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 computerized systems.

Bachelor’s or Master’s Degree in Science (Chemistry) or Engineering Degree (Chemical, Mechanical/Electrical).
Competent knowledge of Computer Systems Validation.
Knowledge of Network Infrastructure Qualification
Knowledge of cGLP/cGMP/cGCP/21 CFR Part 11 requirements in a regulated environment.
Knowledge of MES is an advantage.

Please apply now for more information.

Vicky Miller

Quanta's recruiter for this job is Vicky Miller

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