Compliance Documentation & Training Specialist
Dompé
/job-details/2373
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Dompé is an Biopharmaceutical company driven by innovation and research, with headquarters in Milan and operations across Europe and the United States. The company focuses on developing and delivering therapeutic solutions in areas of high unmet medical need, combining scientific excellence, digital innovation, and a strong commitment to improving patients’ lives.
For our office in
**Tirana**
we are looking for an
**Compliance documentation and training specialist.**
The Compliance Specialist will support the Global Compliance Systems and Tools Manager by performing key operational day-to-day tasks such as the timely execution of documentation updates, training coordination, CAPA follow-up, data analysis, and monitoring activities at a local level, as well as selected operational tasks supporting the local compliance program in Albania & Kosovo.
**Responsibilities:**
**Global Compliance Support Tasks**
- **Documentation Management (EU non‑GxP Policies & Procedures)**
- Ensure that EU non‑GxP POL/SOP are aligned with mandatory company formats and metadata requirements.
- Provide periodic reporting of POL/SOP EU non‑GxP revision and maintenance activities.
**Training Coordination (EU)**
- Manage the global e‑learning tool, ensuring smooth platform operativity.
- Create training metrics and evidence measuring training effectiveness (completion, test outcomes, trends).
- Support training material development, updates, and formatting.
- Ensure updated content is uploaded to the intranet and the Compliance Library.
- Monitor and reproduce training conduction reports and effectiveness metrics for Compliance EU/US.
**Global Compliance Monitoring & Due Diligence**
- Support corrective and preventive actions (CAPA) lifecycle follow‑up, including evidence collection and tracking.
- Conduct data recollection and analysis related to CAPA and TPDD to support reporting to global leadership.
**Local Compliance Support**
- **Policies & Procedures**
- Support in drafting and implementing localized compliance procedures and ensure alignment with global standards and local regulations.
**Training**
- Identify local training priorities by gathering data and inputs from business functions.
- Monitor training completion and effectiveness metrics.
**Response & Corrective Actions**
- Support root‑cause analysis activities by gathering evidence and organizing documentation.
- Track implementation of corrective action plans.
**Auditing & Monitoring**
- Support internal auditing actions and act as a key contact point for the global auditing team.
- Conduct local business monitoring activities in Albania and Kosovo.
**Qualifications**
- University degree Law, Economics or equivalent – minimum bachelor’s degree or equivalent work experience
**Required Skills**
- Strong sense of integrity and accountability.
- Ability to follow structured procedures and maintain high-quality documentation.
- Proactive and solution‑oriented approach.
- Ability to collaborate across global and local teams.
- Professional handling of sensitive or confidential information.
For our office in
**Tirana**
we are looking for an
**Compliance documentation and training specialist.**
The Compliance Specialist will support the Global Compliance Systems and Tools Manager by performing key operational day-to-day tasks such as the timely execution of documentation updates, training coordination, CAPA follow-up, data analysis, and monitoring activities at a local level, as well as selected operational tasks supporting the local compliance program in Albania & Kosovo.
**Responsibilities:**
**Global Compliance Support Tasks**
- **Documentation Management (EU non‑GxP Policies & Procedures)**
- Ensure that EU non‑GxP POL/SOP are aligned with mandatory company formats and metadata requirements.
- Provide periodic reporting of POL/SOP EU non‑GxP revision and maintenance activities.
**Training Coordination (EU)**
- Manage the global e‑learning tool, ensuring smooth platform operativity.
- Create training metrics and evidence measuring training effectiveness (completion, test outcomes, trends).
- Support training material development, updates, and formatting.
- Ensure updated content is uploaded to the intranet and the Compliance Library.
- Monitor and reproduce training conduction reports and effectiveness metrics for Compliance EU/US.
**Global Compliance Monitoring & Due Diligence**
- Support corrective and preventive actions (CAPA) lifecycle follow‑up, including evidence collection and tracking.
- Conduct data recollection and analysis related to CAPA and TPDD to support reporting to global leadership.
**Local Compliance Support**
- **Policies & Procedures**
- Support in drafting and implementing localized compliance procedures and ensure alignment with global standards and local regulations.
**Training**
- Identify local training priorities by gathering data and inputs from business functions.
- Monitor training completion and effectiveness metrics.
**Response & Corrective Actions**
- Support root‑cause analysis activities by gathering evidence and organizing documentation.
- Track implementation of corrective action plans.
**Auditing & Monitoring**
- Support internal auditing actions and act as a key contact point for the global auditing team.
- Conduct local business monitoring activities in Albania and Kosovo.
**Qualifications**
- University degree Law, Economics or equivalent – minimum bachelor’s degree or equivalent work experience
**Required Skills**
- Strong sense of integrity and accountability.
- Ability to follow structured procedures and maintain high-quality documentation.
- Proactive and solution‑oriented approach.
- Ability to collaborate across global and local teams.
- Professional handling of sensitive or confidential information.
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