Compliance Utilities GMP
Walloon Brabant – contracting
Your responsibilities?
Management of Utilities Deviations:
- Handle utilities-related deviations, primarily focusing on fluid systems, with an emphasis on OOS/OIT deviations.
- Use Scoop Compliance tools to manage and track deviations, with a particular focus on utilities
- Manage deviations related to periodic controls and automation
- Write, analyze, and track investigations to ensure compliance with corrective actions.
- Propose and monitor improvement plans and Corrective and Preventive Actions (CAPA).
Support and Interdepartmental Collaboration:
- Collaborate with QC laboratories, fluid production managers, automaticians, and QA/instrumentation teams to ensure compliance and proper system functionality.
- Work closely with on-site teams, understanding the technical issues related to utilities and fluids, without necessarily being a technical expert.
Your profile?
- Scientific background (or equivalent acquired through professional experience)
- Knowledge of utilities processes in the pharmaceutical industry and the GMP regulations associated
- Experience in managing deviation flows (QA, qualification, fluid management). In-depth technical knowledge of fluids is not necessary, but experience in this field is a plus.
- Ability to ask questions and take a step back when facing dysfunctions.
- Strong communication skills (French is essential, basic English is sufficient).
- A proactive person capable of working autonomously while being solution-oriented.
Our offer?
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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
