Equipment Compliance Specialist
Brabant Wallon – contracting
Your responsibilities?
The primary objective of this role is to provide analytical systems expertise to implement equipment supporting the management of physico-chemical method development activities from early clinical phases through to commercial stages.
The main activities of this position will be:
- Manage specific projects for the deployment of analytical equipment, including planning, execution, and follow-up, to ensure effective and timely implementation.
- Collect user requirement specifications for new equipment, ensuring alignment with project objectives.
- Prepare and maintain detailed documentation for each project, including URS, DV, IMA, and logbooks.
- Coordinate with suppliers to manage equipment orders and ensure on-time delivery. Contribute to supplier qualification processes.
- Plan and coordinate IT and qualification activities based on forecasted equipment usage.
- Facilitate IQOQ activities conducted by vendors (Vendor IQOQ).
- Ensure compliance of all project activities with GMP/GSP regulations, cybersecurity requirements, safety protocols, and internal procedures.
- Provide support for system administration tasks, including the creation of new systems in ELN and review of VSL inventory compliance.
- Manage and resolve issues that may arise during the equipment deployment process and during their transition into routine operation (e.g. contract reviews)
Your profile?
- Master’s or bachelor’s degree in biochemistry or in analytical chemistry
- At least 5 years of experience in the pharmaceutical industry
- A good knowledge (and if relevant laboratory expertise) in at least one of the analytical techniques used in the laboratory: chromatography or electrophoresis capillary (CE, MAURICE,…) or spectrophotometry derived equipment (ICP, SoloVPE, Spectramax, FT-IR, …)
- Ability to author and review comprehensive and accurate procedures, protocols, and reports.
- A good knowledge of GLP/GMP rules.
- A good level of English is recommended for reports and oral communication.
- Ability to handle multiple priorities and/or prioritization.
- Interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
- Ability to work in a matrix and customer-oriented environment.
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.