Analytical Development GMP Compliance Specialist

Contracting – Brabant Wallon 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. Compliance Monitoring 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. Minimum 5-7 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) 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, lena.palmeri@jeffersonwells.be GAMP, Installation, GMP, Communication, Training Records, Internal Policies, End Users, Practicality, Audit, Data integrity, Quality systems, Stakeholders, 21 CFR Part 11, Procurement, Inspection, Investigations, Support Network, Design, Quality systems, Coordination, VOS, Metric, Leadership, Organization Skills, Equipment Selection, Point of contact, Remediation, URS, Problem Management, Logbooks, Inventory Records, CAPA, System integration, CMC

Location: Braine-l'Alleud, 1420, BE

Posted Date: 10/2/2025