Compliance Advisor II supporting enterprise - wide compliance operations at AltaMed. Involves audits, training, policy drafting, and compliance queries with healthcare focus.
About the role
- 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.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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