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 System Technician.
Job Summary
We are seeking a Quality Systems Technician to support and maintain the Quality Management System (QMS) in compliance with FDA, EU GMP, and ICH Q7 regulations for API manufacturing. This role will focus on GMP documentation management, deviation handling, CAPA coordination, change control, and continuous improvement initiatives to ensure regulatory compliance and operational excellence.
The selected candidate will work closely with QA, QC, Manufacturing, Engineering, and Regulatory Affairs to ensure that all quality systems align with regulatory expectations and company policies.
Job description
The primary responsibilities of the QA System Technician include:
Key Responsibilities
1. Quality Management System (QMS) Compliance
Support the maintenance and continuous improvement of the Quality Management System (QMS) in compliance with EU GMP, FDA 21 CFR Part 210/211, and ICH Q7.
Manage and update GMP documentation, including Standard Operating Procedures (SOPs), Work Instructions, Quality Policies, and Batch Records.
Monitor compliance with Good Documentation Practices (GDP) and Data Integrity (ALCOA++ principles).
Monitoring GMP compliance in the production plant through on site inspections and staff interviews
2. Deviation, CAPA Change Control Management
Support the management of deviations, complaints, non-conformities, out-of-specification (OOS), and out-of-trend (OOT) results.
Assist in root cause analysis (RCA) and coordinate Corrective and Preventive Actions (CAPAs).
Support the Change Control process by ensuring risk assessments and regulatory impact evaluations are properly documented.
3. Audit Inspection Readiness
Assist in the preparation and execution of internal audits, regulatory inspections (FDA, EMA, local authorities), and customer audits.
Ensure audit findings and regulatory observations are adequately addressed through CAPAs.
4. Quality Risk Management Continuous Improvement
Support the implementation of Quality Risk Management (QRM) principles and risk-based decision-making.
Participate in cross-functional projects to improve QMS processes and GMP compliance.
Support GMP training initiatives for personnel to enhance quality awareness.
Participate in GMP training sessions to enhance compliance awareness across departments.
5. Documentation Data Integrity Oversight Regulatory support
Candidate profile
Education Experience:
Bachelors degree in pharmacy, Chemistry, Biotechnology, Life Sciences, or a related field.
3-5 years of experience in QA within an API, Biotech, or pharmaceutical environment. Experience in API industry is an advantage.
Strong knowledge of FDA 21 CFR Part 210/211, EU GMP, ICH Q7 (GMP for APIs), and Data Integrity (ALCOA++ principles).
Skills Competencies: