Spécialiste Compliance QC ensuring regulatory compliance and improving quality processes in a laboratory. Supporting QC teams and managing quality investigations in a hybrid work environment.
Responsibilities
Operational support and compliance.
Support QC teams in their daily activities by providing expertise on all compliance and quality requirements.
Actively participate in data analyses and document reviews in accordance with internal and regulatory standards.
Monitor, investigate, and close discrepancies, non-conformances, deviations, and change controls in coordination with QC experts.
Lead or contribute to periodic reviews and ensure compliance with documentation timelines and requirements.
Propose and track corrective and preventive actions (CAPA).
Develop and strengthen the Data Integrity culture within the laboratory.
Perform or support Data Integrity risk analyses, implement associated action plans, and report to management.
Identify opportunities to improve quality practices, procedures and tools, and contribute to their implementation.
Draft, review and maintain SOPs, work instructions and other quality documents related to QC.
Monitor regulatory and pharmacopeial developments that may impact quality control activities.
Participate in the preparation and execution of internal and external audits (regulatory or client).
Requirements
Scientific degree (biology, chemistry, biotechnology or equivalent).
Significant experience in a QC laboratory or in quality assurance within a GMP environment.
Strong understanding of QC processes, GxP requirements and data integrity principles.
Strong writing skills, attention to detail and the ability to manage multiple topics simultaneously.
Excellent communication and collaboration skills in a cross-functional environment.
Benefits
Expleo offers a unique portfolio of integrated engineering, quality and strategic consulting services for digital transformation.
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