Validation Engineer CSV

Il y a 8 heures

Geel, Flanders, Belgique Arcadis Temps plein

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We are looking for a validation engineer who has project experience with validation of software packages and computerized systems.

The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.

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.
Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerized systems.
Responsible for the validation documentation through approval and implementation.
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 Procedures.
Ensures that the Validated Status of computerized systems is in compliance with cGMP at all times.
Ensures projects are managed in conjunction with all 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.
Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.
Investigates/troubleshoots validation issues.

Skills/experience:

Strong communication skills.
Capable of working independently and learns fast.
Able to execute project to plan.
Competent knowledge of Computer Systems Validation.
Full understanding of relevant quality and compliance regulations.
Capable of troubleshooting validation issues.
Minimum 3 years experience working in a pharmaceutical sector and GMP environment. xirbnpk
Good knowledge English and Dutch.