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!