Description
A multinational pharmaceutical organisation requires an experienced CSV MES Specialist to join their Pharmaceutical manufacturing facility in Ireland.Key Accountabilities:
. 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 Genzyme 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.
Experience Required:
. 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 Werum Pas-X
Please apply now for more information.