обновлено 7 дней назад
GCP Specialist R&D (Auditing)
39 000€
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
GCP Specialist R&D (Auditing): Ensuring compliance with Good Clinical Practices (GCP) and managing quality systems within the R&D department with an accent on CAPA management, audit execution, and quality documentation. Focus on maintaining high standards of regulatory compliance, supporting clinical trial integrity, and optimizing quality metrics across global R&D operations.
Location: Must be based in or able to work from Parma, Italy (Hybrid arrangement).
Salary: From €39,000 per year.
Company
is an international research-focused biopharmaceutical group dedicated to developing innovative drugs and promoting a healthier world.
What you will do
- Manage CAPA plans resulting from GCP audits.
- Collect and report quality metrics and KPIs for Global R&D departments.
- Execute first and second-party GCP audits.
- Write and review SOPs related to the audit and qualification of clinical service providers.
- Manage Trackwise, supplier, and audit workflows.
- Ensure proper documentation, traceability, and training on relevant procedures.
Requirements
- Scientific degree required.
- At least 1 year of experience in QA within the pharmaceutical, consultancy, or CRO sector.
- Strong knowledge of GCP requirements and pharmaceutical development processes.
- Good command of English.
- Ability to manage quality systems and compliance documentation.
Nice to have
- Knowledge of auditing techniques.
- ISO auditor certification.
Culture & Benefits
- Comprehensive benefits package including pension and private medical insurance.
- Flexible hybrid working arrangements.
- Access to professional development, training, and wellbeing programs.
- Supportive environment within a certified B Corp organization.
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