Qa-It Technician

hace 2 semanas

Barcelona, Barcelona, España Uquifa A tiempo completo

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 SummaryWe 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:
• Develop and execute Validation Plans (VP), User Requirement Specifications (URS), Functional Specifications (FS), IQ, OQ, PQ protocols, and validation reports.
• Ensure proper Change Control and Decommissioning procedures for computerized systems.
• Maintain an updated inventory of GMP-relevant IT systems and their validation status.
• Evaluate systems for compliance, including:o Backup/Restoreo Disaster Recovery Plan (DRP)o Risk analysiso 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:
• Work closely with IT, Quality, and Manufacturing teams to ensure proper system implementation and maintenance.
• Ensure compliance with cybersecurity best practices for GMP-related IT systems.
• Assist in vendor qualification and oversight for third-party
• Comply with General Prevention Standards (Reception Manual) and SOPs relevant to the job, understanding and implementing Risk Assessment and preventive measures.
• Report risk situations, incidents, and accidents, as well as any conditions that impact work ability, and propose workplace improvements.
• Use machinery, tools, hazardous substances, and equipment in accordance with safety regulations and preventive measures.
• Correctly use Personal Protective Equipment (PPE) and collective safety equipment.
• Act in compliance with all internal and external laws, regulations, and standards within the scope of responsibility.
• Adhere to UQUIFA Group's ethical, regulatory, and compliance standards in all professional interactions.
• Immediately report any potential concern or violation of UQUIFA Group's Code of Ethics and Conduct, the law, or internal regulations through official channels.The QA IT Technician will report to the QA Compliance Coordinator at Sant Celoni and be based on-site.Education Experience:
• Bachelor's degree in Computer Science, Engineering, Pharmacy, Biotechnology, or a related field.
• 3+ years of experience in QA IT, CSV, or Data Integrity within a GMP-regulated environment (Pharmaceuticals, API Manufacturing, or Biotech).
• Strong knowledge of EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity requirements.
• Experience in validation of ERP, LIMS, MES, SCADA, PLCs, and electronic batch records (eBMR/eBR) is a plus.Skills Competencies:
• Fluent in English; knowledge of other languages is a plus.
• Strong analytical skills and problem-solving mindset.
• Ability to work cross-functionally with IT, Quality, and Manufacturing teams.
• Experience in managing audits and interacting with regulatory authorities.
• Excellent business acumen with a deep understanding of organizational priorities and operational processes that drive profitable growth.
• High resilience and ability to adapt to a dynamic work environment.If you are looking for an opportunity to contribute to a leading API manufacturer and be part of a collaborative and innovative team, we would love to hear from you
Apply now and join UQUIFA Group in shaping the future of pharmaceutical manufacturing.

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