Location: Belgium, Brussels
Employment Type: Contract / Full-time
Duration: Long-term project
Project Overview:
We are seeking a skilled professional to support a project focused on documenting and validating software installed on lab instrumentation in line with the new EMA guidelines. The role also involves migrating software management to PPD IT software management SOPs while ensuring compliance with GxP and GAMP5 standards.
Key Responsibilities:
* Gather and document user and system requirements (URS) and software configurations.
* Develop and execute validation protocols (IQ, OQ, PQ where applicable).
* Prepare requirements specifications, infrastructure diagrams, and data flow documentation.
* Perform risk assessments and maintain full traceability between requirements, risks, tests, and results.
* Support SOP migration and ensure alignment with IT and QA standards.
* Collaborate closely with lab teams, IT, QA, and vendor partners to ensure smooth delivery.
Scope of work:
* Document and validate software installed on laboratory instruments according to EMA / Annex 11 / GAMP 4 guidelines.
* Migrate existing processes and documentation to align with IT SOPs and compliance frameworks.
* Capture and maintain detailed requirements, configurations, and validation documentation.
Required Skills & Qualifications:
* Proven experience in software validation within GxP / laboratory systems.
* Strong technical writing and documentation abilities.
* Solid understanding of EMA guidelines, Annex 11, and GAMP 4 principles.
* Ability to create system architecture, infrastructure, and data flow diagrams.
* Excellent attention to detail, communication, and stakeholder management skills.
Why Join Us?
* Opportunity to work on a high-impact project ensuring compliance with the latest EMA regulatory guidelines.
* Collaborate with global teams in a science-driven, regulated environment.
* Gain hands-on experience with lab software validation and regulatory compliance.
We’re grateful for your interest in joining our team. Kindly note that only applicants whose experience and qualifications most closely align with the role will be contacted for the next steps. Thank you for your understanding.