Qualification and Validation Engineer
Antwerpen – Contracting
Our partner is looking for an Qualification & Validation Engineer to join its team. This international company is well known for its pharmaceuticals.
What are your responsibilities?
- Develops, implements and executes URS, CAT, SIA, DQ, IQ, OQ, PQ, RV and TM activities for small scale equipment in QC and Manufacturing, including the related software. Develops, implements and executes validation studies for cGMP-critical process systems to demonstrate compliance with cGMP, user and regulatory requirements. This role involves hands-on activities.
- Performs qualification of systems in scope where industry precedence exists, but where standards require case-specific interpretation. Ensures all activities are in accordance with cGMP, cGLP and Sanofi Procedures.
- Ensures that the qualified status of systems in scope is in compliance with cGMP at all times.
- Supports projects in conjunction with all required Sanofi and cGMP regulatory standards.
- Maintains current knowledge 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.
- Takes responsibility for the validation documentation through approval and implementation.
- Provides input in the review and assessment of changes to assess whether they impact the qualified status and validation documentation, as appropriate.
Who are you?
- Knowledge of cGMP requirements in a regulated environment.
- Understanding of relevant quality and compliance regulations.
- Ability to troubleshoot validation issues.
- Good knowledge of quality management systems.
- Experience: 2-4 years working in a healthcare manufacturing environment, with experience in qualification of small scale equipment (including the related software).
What can you expect?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.