SAP Authorization Specialist

Seargin; Valencia; Presencial; EUR 30.000 - 60.000; Jornada completa

Descripción de la vacante

Una firma innovadora busca un profesional en cumplimiento GMP para respaldar la estrategia de cumplimiento GxP en un entorno dinámico. Este rol implica colaborar con el gerente de cumplimiento para garantizar que las auditorías internas se realicen de acuerdo con las regulaciones y estándares aplicables. El candidato ideal tendrá una sólida formación en Ciencias de la Vida y experiencia en Aseguramiento de Calidad, además de ser proactivo y flexible. Esta es una oportunidad emocionante para contribuir a la mejora continua en un entorno de fabricación de alta calidad y cumplir con los estándares regulatorios globales.

Formación

• 3-4 años de experiencia relevante en el área de Aseguramiento de Calidad.
• Licenciatura en Ciencias de la Vida o Farmacia es un plus.

Responsabilidades

• Apoyar al gerente de cumplimiento GMP en auditorías internas y documentación.
• Colaborar en la preparación de inspecciones de autoridades regulatorias.

Conocimientos

Inglés avanzado

Flexibilidad

Iniciativa / Proactividad

Planificación y organización

Educación

Licenciatura en Ciencias de la Vida

Licenciatura en Farmacia

Herramientas

Paquete Office

E-mail

Internet

Descripción del empleo

Descripción del trabajo: 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 to collect information needed for the development of a global risk-based internal audit programme 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. Assist during the definition and recording of mitigation plans.
6. Participate during the adequacy assessment of CAPA plans to internal audit findings in cooperation with QA, operations stakeholders, and auditees.
7. Collaborate during the development of GMP / GDP compliance policies for ITF manufacturing sites and affiliates.
8. 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.
9. Ensure applicable staff is integrated into Global GxP compliance systems and tools.
10. Record, investigate, and escalate to GMP Compliance Manager any deviation from GMP / GDP global policies and procedures.

Other activities performed can be, but are not limited to:

To support Corporate and Global GxP Functions:

1. Issuing, reviewing, or approving policies, procedures, or applicable Quality Documentation.
2. Preparing GxP Global Compliance metrics in order to extrapolate data and to 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 programmes.
4. Collaborating with Global GxP Compliance Director and compliance staff in the preparation of the Regulatory Authorities' Inspections and ensuring the necessary assistance to inspectors during the inspections.
5. Supporting compliance with GxP requirements for Global / Corporate Computerized System (e.g., eDMS, Pragma, and regulatory intelligence tools), involving but not limited to the review and approval of validation documentation.
6. To be constantly 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. Use of computer tools (PC, E-mail, Office Package, Internet).

Competencies: Flexibility, Initiative / Proactivity, Planning, organizing, controlling.