CSV Specialist for Global eQMS

hace 3 días

Alcobendas, Madrid, España Italfarmaco A tiempo completo

We are looking for a proactive and detail‑oriented CSV Specialist to join our team and take ownership of our Pragma electronic quality management system. This role is ideal for someone who enjoys working at the intersection of quality, digital tools, and process optimization. You will be responsible for maintaining, improving, and supporting the system, ensuring data integrity, and enabling teams to use it effectively.

If you're passionate about digital quality systems, comfortable working with structured data, and eager to collaborate across corporate departments, this role is for you.

Key Responsibilities:

  • Serve as the primary administrator and subject‑matter expert for the Pragma eQMS.
  • Configure, maintain, and optimize system modules, workflows, and user permissions.
  • Ensure data accuracy and integrity, including importing/exporting data using CSV formats.
  • Provide technical support to internal users, troubleshoot issues, and coordinate with the vendor when needed.
  • Develop and maintain SOPs, training materials, and documentation related to the system.
  • Train new and existing users on system functionalities and best practices.
  • Collaborate with Quality, IT, Operations, and other teams to ensure alignment with compliance requirements.
  • Support audits and inspections by preparing system data and documentation.
  • Participate in continuous improvement initiatives related to digital quality processes.
  • Travel occasionally to company sites or partner locations as required.

Required Qualifications:

  • Proven experience working with electronic quality systems, ideally Pragma (or similar eQMS platforms).
  • Strong understanding of CSV data handling, structured data, and basic data transformation.
  • Solid technical literacy and ability to learn new software tools quickly.
  • Excellent communication skills with C1‑level English (spoken and written).
  • Ability to work independently, manage priorities, and support multiple stakeholders.
  • Willingness and ability to travel as part of the role.

Preferred Qualifications (Nice to Have):

  • Experience in regulated industries (pharma, biotech, medical devices, manufacturing, etc.).
  • Knowledge of quality processes such as CAPA, Change Control, Document Management, or Training Management.
  • Familiarity with validation principles (CSV — Computer System Validation).
  • Experience with data analysis or reporting tools.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and training.
  • Exposure to digital transformation initiatives within the quality domain.

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