The purpose of this role is to support GMP compliance manager to ensure GMP/GDP compliance across ITF group manufacturing sites and affiliates in alignment to evolving regulatory landscape. This role will also assist the team with the preparation of Health Authority Inspections documentation and support compliance team in the implementation of GxP compliance strategy across Italfarmaco Group.
Main Responisilities:
Support GMP Compliance Manager to ensure Health Authority Inspections remediation activities are undertaken, implemented, and the effectiveness verified at the respective sites and affiliates. Assist GMP Compliance Manager to collect information needed for the development of a global risk-based internal audit programm for manufacturing sites and affiliates working under GMP and GDP regulations. Assist GMP compliance Manager planning, and conducting GMP/GDP internal audits according to the requirements specified in company procedures, applicable regulations, standards, quality agreements and guidance documents. Prepare audit reports based on company requirements and timelines. Ensure appropriate escalation to responsible management in case of critical findings and support follow up measures. Assist during definition and recording of mitigation plans. Participate during the adequacy assesment of CAPA plans to internal audit findings in cooperation with QA, operations stakeholders and auditees. Collaborate during the development of GMP/GDP compliance policies for ITF manufacturing sites and affiliates. 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. Ensure applicable staff is being integrated in Global GxP compliance systems and tools. Record, investigate and escalate to GMP Compliance Manager any deviation to GMP/GDP global policies and procedures. Other activities performed can be, but not limited to:
To support Corporate and Global GxP Functions: a) Issuing, reviewing or approving policies, procedures or applicable Quality Documentation. b) Preparing GxP Global Compliance metrics in order to extrapolate data and to update upper management Global Compliance Director. c) Collaborating with Global GxP compliance team for the development and execution of global risk-based internal and external audit programmes. d) Collaborating with Global GxP Compliance Director and compliance staff in the preparation of the Regulatory Authorities' Inspections and ensure the necessary assistance to inspectors during the inspections. e) Supporting the compliance with GxP requirements for Global/Corporate Computerized System (e.g eDMS,Pragma and regulatory intelligence tools), involving but no limited to the review and approval of validation documentation. f) To be constantly updated on industry regulations and quality news.
Requirements:
Bachelor’s degree in Life Sciences /Sciences/ Biomedical matters. Pharmacy degree is a plus. At least 3- 4 year of relevant experience in Quality Assurance area. Good English proficiency. Use computer tools (PC, E-mail, Office Package, Internet). Competencies Flexibility. Initiative / Proactivity. Planning, organizing, controlling.