descripción del trabajo

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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We invite you to join our upcoming hiring processes.

#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.