Description
Proteus Europe is searching for a Computer System Validation (Junior) for a 6 month contract role based in Wavre, Belgium.Our Client :-
Our client is an international consultancy with a reputation for delivering on projects with their consultancy customers. You will join and be part of their team to ensure this current project is a complete success. The end client is one of the worlds largest Pharmaceutical companies.
Your New role :-
Support computer system validation and qualification through its development life cycle and according to relevant policies, procedures and standards.
- Support the IT Risk and Compliance manager in reviewing system documentation through the system life cycle (e.g. validation plans, risk assessments, user requirements and functional specifications, test protocols and executed test protocols during design, infrastructure, operational and performance qualification phases).
- Follow-up delivery of system documentation and report progress to his/her manager.
- Document and follow-up IT deviations and CAPAs.
- Provide trainings on computer system validation.
- Provide advices to his/her manager on computer system validation process improvement.
- Assist during audit and participate to inspection readiness program.
- Assist in the evaluation of IT risks.
Your Skills and experience :-
Essential Skills :-
Knowledge/skills
- Good knowledge of IT processes and the IT validation model (e.g. GAMP).
- Basic understanding of general information systems risks and controls.
- Basic understanding of Pharmaceutical (GMP/GCP/GLP) and/or Financial (Sarbanes-Oxley) regulations.
- Good problem solving, conflict resolution, communication and writing skills.
- Fluent in English (written and verbal). Knowledge of French is an asset.
Experience
- Minimum 6 months work experience in computer system validation/qualification or IT Quality
Assurance.
Proteus Europe operates in partnership with our candidates by
building strong and lasting relationships at all levels.
If you apply for this role, we will:
- Contact you within one week to discuss your current
situation and suitability for this role.
- Keep searching for other suitable positions should this role not
be right for you.
- Keep you informed at every stage of the recruitment process.
- Actively follow up with our client on your behalf to gain useful
feedback throughout the process.
If you are looking for a new role, but this role isn't quite right for
you, please contact us in confidence for a discussion about
how we can help you.