Global GMP Compliance Specialist, Madrid
Location: Madrid, Spain
Job Category: Other
EU work permit required: Yes
Job Description:
The purpose of this role is to support the GMP Compliance Manager in ensuring GMP/GDP compliance across ITF group manufacturing sites and affiliates, in line with evolving regulatory requirements. The role also involves assisting with the preparation of documentation for Health Authority Inspections and supporting the implementation of GxP compliance strategies within the Italfarmaco Group.
Main Responsibilities:
1. Support GMP Compliance Manager in managing Health Authority Inspection remediation activities, ensuring they are completed, implemented, and their effectiveness verified at respective sites and affiliates.
2. Assist in collecting information for developing a global risk-based internal audit program for manufacturing sites and affiliates under GMP and GDP regulations.
3. Assist in planning and conducting GMP/GDP internal audits according to company procedures, regulations, standards, and guidance documents. Prepare audit reports and ensure timely escalation of critical findings.
4. Participate in defining and recording mitigation plans and assess the adequacy of CAPA plans in collaboration with QA, operations, and auditees.
5. Collaborate in developing GMP/GDP compliance policies for ITF manufacturing sites and affiliates, ensuring procedures are communicated and staff training is implemented.
6. Record, investigate, and escalate deviations from GMP/GDP policies to the GMP Compliance Manager.
7. Support activities such as issuing, reviewing, or approving policies and procedures; preparing compliance metrics; collaborating on audit programs; assisting during regulatory inspections; supporting GxP computer system compliance; and staying updated on industry regulations.
Requirements:
* Bachelor’s degree in Life Sciences, Sciences, Biomedical fields; Pharmacy degree is a plus.
* At least 3-4 years of relevant experience in Quality Assurance.
* Proficiency in English and computer tools (PC, email, Office Suite, Internet).
Competencies:
* Flexibility, initiative, proactivity, planning, organizing, controlling.
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