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 integral 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.
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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.