Added: 2025-05-28 16:09.00
Updated: 2025-05-30 03:38.31

QA-IT Technician

Sant Celoni , Catalonia, Spain

Type: n/a

Category: IT & Internet & Media

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Requirements: English
Company: UQUIFA
Region: Sant Celoni , Catalonia

Company overview:

With over 85 years of experience, UQUIFA Group is a leading manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates, serving the pharmaceutical and animal health industries worldwide. Operating under cGMP conditions, our two manufacturing sites in Spain and Mexico have been inspected and approved by leading global pharmaceutical companies and regulatory authorities, including the US FDA. Since 2018, Soneas Chemicals Ltd., a Budapest-based company focused on CDMO activities, has been part of the UQUIFA Group, enhancing our capabilities in route scouting, process optimization, and both small- and large-scale manufacturing. Our commitment to innovation, quality, safety, passion, environmental sustainability, and flexibility drives us to deliver excellence to our clients in over 70 countries.
Our plant in Sant Celoni is looking to hire a QA IT Technician.

Job Summary

We are looking for a QA IT Specialist to ensure compliance with EU GMP, FDA 21 CFR Part 11, and Data Integrity requirements within IT systems used in GMP-regulated activities. This role will focus on the validation, qualification, and lifecycle management of computerized systems supporting manufacturing, quality control, and regulatory compliance processes in an API manufacturing

1. IT Quality Compliance:
Ensure GMP compliance of IT systems in accordance with EU GMP Annex 11, FDA 21 CFR Part 11, and Data Integrity guidelines.
Implement and maintain CSV (Computer System Validation) strategies following GAMP 5 principles.
Support risk assessments for computerized systems to define validation approaches.
Collaborate with IT and quality teams to establish data integrity policies and ALCOA+ principles.
Develop procedures (SOP) and policies associated with computerized systems.
2. Validation Qualification:

o Backup/Restore
o Disaster Recovery Plan (DRP)
o Risk analysis
o Systems Development Life Cycle (SLC/SDLC)
o CAPA (Corrective Actions/Preventive Actions)
3. Support Audits:
Act as a key point of contact during regulatory inspections (FDA, EMA, local authorities) and internal/external audits regarding IT compliance.
Support deviation investigations and CAPA implementation related to computerized systems.
Provide training to users on GMP-compliant use of IT systems.
4. IT System Lifecycle Management:

Education Experience:

Skills Competencies:

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