Validation Engineer CSV

Il y a 3 heures

Geel, Flanders, Belgique Arcadis Temps plein
We are looking for a validation engineer who has project experience with validation of software packages and computerized systems. 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.
- Good knowledge English and Dutch.