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! 🚀
Supervise and control regulatory compliance in computerized pharmaceutical systems.
Coordinate with multidisciplinary teams to implement effective validation processes.
Drive continuous improvement in quality and validation practices on-site.
What do you need? 🤓
* Degree in Sciences. Master’s degree is a plus.
* Over 1 year of experience in similar roles in Computer System Validation and Quality Assurance, preferably at an international level.
* Solid knowledge of GMP and CFR standards, their interpretation, and application.
* Experience with EMA, FDA regulations, and pharmaceutical industry associations.
* Fluent in Spanish and English;
additional languages are a plus.
* Willingness to travel occasionally.
Our benefits! 👏
📜 Permanent contract
🏥 Health insurance
📈 Opportunities for professional development and continuous training
🎯 Participation in innovative international projects
Selection process 🕵️
* Initial contact via phone or email.
* 1 or 2 interviews either onsite or virtual.
* Continuous communication about the process status to keep you informed.
🔷 Think this offer is not for you? 🔷
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#Chemo #Challenger #InsudPharma #InsudTalent
COMMITMENT TO EQUAL OPPORTUNITIES
At CHEMO, we promote gender equality and guarantee an inclusive environment, free from discrimination based on ethnicity, religion, sexual orientation, disability, or any other condition.