IT Compliance

hace 2 semanas

Azuqueca de Henares, España Chemo A tiempo completo

In a few words

Position: IT Compliance

Location: Azuqueca de Henares, Spain (on-site)

Experience: Over 1 year in similar roles in computer system validation and quality assurance

Want to know more?

CHEMO, part of the INSUD PHARMA group, is a global leader in pharmaceutical industrial operations with a strong commitment to innovation and sustainable development. Joining CHEMO means being part of a company that contributes to human and animal health through excellence in pharmaceutical development and manufacturing.

Ready to be a #Challenger?

What are we looking for?

- Validate computerized systems at site level together with the Quality Department, ensuring compliance with CFR 21 part 11, Annex 11, and GMP regulations.
- Prepare validation documentation in accordance with current regulations and GAMP5 recommendations.
- Perform periodic reviews to maintain the validated status of computerized systems.
- Ensure proper execution of GxP activities derived from SOPs.
- Establish maintenance and validation plans in collaboration with the Quality Department.
- Manage system and plant infrastructure validation.
- Promote and enhance quality culture and data integrity on-site, aligned with GAMP5 in validation, security, and lifecycle management.

The challenge

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