Analytical Development GMP Compliance Specialist
Contracting – Brabant Wallon
YOUR RESPONSIBILITIES :
GMP Compliance & Operational Excellence:
* Support the harmonization and alignment of GMP practices with internal policies, SOPs, and external regulatory standards.
* Contribute to audit and inspection readiness by collaborating with internal stakeholders.
* Identify and implement continuous improvement initiatives to optimize compliance and efficiency.
* Monitor key compliance metrics such as deviations, CAPAs, overdue SOPs, and training records.
* Oversee environmental monitoring activities and manage associated investigations.
* Serve as a point of contact for deviation management within the quality system.
* Identify potential compliance gaps and drive remediation actions.
Analytical Equipment Deployment:
* Lead the deployment of new analytical equipment from selection to GMP release.
* Gather and define URS with end users and stakeholders.
* Coordinate with suppliers, manage procurement timelines, and support qualification efforts.
* Develop and maintain project documentation including URS, design verification, installation records, and logbooks.
* Facilitate vendor qualification activities (IOQ) and support system integration (e.g., electronic notebook setup).
* Maintain accurate inventory records and ensure data integrity and compliance of all systems.
YOUR PROFILE :
* Minimum 4 years of experience in a GMP-regulated environment.
* Strong knowledge of GMP, GAMP, 21 CFR Part 11, equipment qualification, and computerized system validation.
* Hands-on experience in compliance monitoring, analytical or CMC functions, and quality systems (deviations, CAPAs).
* Proven ability to lead cross-functional initiatives and manage initiatives in a regulated setting.
* Excellent communication, problem-solving, and organizational skills.
* Proficiency in French and English (written and spoken)
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.