The purpose of this role is to support the GMP Compliance Manager to ensure GMP/GDP compliance across ITF group manufacturing sites and affiliates in alignment with the evolving regulatory landscape. This role will also assist the team with the preparation of Health Authority Inspections documentation and support the compliance team in the implementation of GxP compliance strategy across Italfarmaco Group.
Main Responsibilities:
1. Support GMP Compliance Manager to ensure Health Authority Inspections remediation activities are undertaken, implemented, and the effectiveness verified at the respective sites and affiliates.
2. Assist GMP Compliance Manager in collecting information needed for the development of a global risk-based internal audit program for manufacturing sites and affiliates working under GMP and GDP regulations.
3. Assist GMP Compliance Manager in planning and conducting GMP/GDP internal audits according to the requirements specified in company procedures, applicable regulations, standards, quality agreements, and guidance documents.
4. Prepare audit reports based on company requirements and timelines.
5. Ensure appropriate escalation to responsible management in case of critical findings and support follow-up measures.
6. Assist during the definition and recording of mitigation plans.
7. Participate in the adequacy assessment of CAPA plans to internal audit findings in cooperation with QA, operations stakeholders, and auditees.
8. Collaborate during the development of GMP/GDP compliance policies for ITF manufacturing sites and affiliates.
9. Ensure procedures and policies are distributed to all staff working under GMP/GDP regulations, track the training, and ensure they are being implemented in applicable local quality management systems.
10. Ensure applicable staff is integrated into Global GxP compliance systems and tools.
11. Record, investigate, and escalate to GMP Compliance Manager any deviation from GMP/GDP global policies and procedures.
12. Support Corporate and Global GxP Functions, including:
1. Issuing, reviewing, or approving policies, procedures, or applicable Quality Documentation.
2. Preparing GxP Global Compliance metrics to extrapolate data and update upper management Global Compliance Director.
3. Collaborating with Global GxP compliance team for the development and execution of global risk-based internal and external audit programs.
4. Collaborating with Global GxP Compliance Director and compliance staff in the preparation of Regulatory Authorities' Inspections and ensuring necessary assistance to inspectors during the inspections.
5. Supporting compliance with GxP requirements for Global/Corporate Computerized Systems (e.g., eDMS, Pragma, and regulatory intelligence tools), including the review and approval of validation documentation.
6. Staying updated on industry regulations and quality news.
Requirements:
1. Bachelor's degree in Life Sciences / Sciences / Biomedical matters. Pharmacy degree is a plus.
2. At least 3-4 years of relevant experience in the Quality Assurance area.
3. Good English proficiency.
4. Proficient in using computer tools (PC, E-mail, Office Package, Internet).
Competencies:
1. Flexibility.
2. Initiative / Proactivity.
3. Planning, organizing, controlling.
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