Clinical Quality Specialist

    EyeDPharma Published: September 16, 2021
    Location
    Liège, Belgium
    Job Type

    Description

    Your responsibilities:

    • The Clinical Quality Specialist will be a part of a quality supportive team that fosters constructive collaboration in support of our clinical development programs.
    • He/She will support and work with our clinical study management team and teammates across R&D Quality.
    • The Clinical Quality Specialist will be a part of a quality supportive team that fosters constructive collaboration in support of our clinical development programs.
    • He/She will support and work with our clinical study management team and teammates across R&D Quality.
    • Serves as Clinical Compliance Lead for assigned clinical trial programs.
    • Handles multiple projects and ensure overall and timely completion of tasks.
    • Develops audit plan for assigned projects and manages audit plan execution.
    • Manages and/or leads GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors.
    • Trains and manages contracts auditors.
    • Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
    • Advises core teams independently for routine compliance inquiries.
    • Assists in readiness preparation, and/or directly support regulatory agency inspection.
    • Assists in coordination of response to any findings.
    • Supports deviation identification, reporting, and CAPA development.
    • Ensures that the monitoring of studies is correctly carried out and supports this activity.
    • Participates in risk management activities.
    • Participates in intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
    • Evaluates, writes and/or reviews operating procedures (e.g. SOPs), and performs other activities in support of an integrated cross-functional quality management system (QMS).
    • Generates and provides metrics, status and trend reports and other information, as required by management.
    • Maintains an up to date and in-depth knowledge of appropriate national and international GCP legislation and guidelines; and the impact on assigned business area processes and procedures.
    • Fosters a commitment to quality in individuals and a culture of quality within the organization.

    Your profile:

    • Master in Science with 8+ years of relevant experience.
    • Minimum 5 years in Good Clinical Practice (GCP) required, with international audit and compliance experience.
    • Recognized as an expert resource on a range of clinical compliance topics.
    • Experience supporting regulatory authority inspections.
    • Participation in process improvement initiatives.
    • Strong verbal and written communication skills and interpersonal skills and facilitation skills.
    • Proficient in Microsoft Office suite.
    • Excellent organization skills and project management, able to manage multiple projects.
    • Able to work equally well as part of a team or independently.
    • Fluent in English.
    • Experience in other GxP areas is an asset.
    • Experience in the Medical Device field is an asset.
    • Proactive and willing to work in a start-up environment.
    • A permanent position in an innovative and dynamic and fast-growing company
    • Full time; Liège.
    • Mots clés: medical device, ophthalmology, development, pharmaceutical, ocular pathologies, research scientist, quality, drug product, life sciences, sciences appliqués, innovation, technical documentation, dispositifs médicaux, ISO14971, ISO13485, Risk management, qualité, clinique, clinical, GCPProfile Group manages this mission in exclusivity.

    Any interested candidate is therefore invited to apply exclusively through this ad (apply now) or by contacting Profile Group directly.

    APPLY HERE 

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