QA Systems Technician

UQUIFA; España; Presencial; EUR 30.000 - 60.000; Jornada completa

Descripción de la vacante

An established industry player in pharmaceutical manufacturing is seeking a Quality Systems Technician to enhance their Quality Management System. This role focuses on ensuring compliance with regulatory standards, managing GMP documentation, and driving continuous improvement initiatives. The ideal candidate will have a strong background in QA within the API or biotech sectors, with expertise in FDA regulations and EU GMP. Join a collaborative team dedicated to excellence and innovation in pharmaceutical manufacturing, and contribute to shaping the future of the industry.

Formación

• 3-5 years of experience in QA within an API or pharmaceutical environment.
• Strong knowledge of FDA regulations and EU GMP standards.

Responsabilidades

• Support maintenance of Quality Management System in compliance with regulations.
• Manage GMP documentation and handle deviations and CAPAs.

Conocimientos

FDA 21 CFR Part 210 / 211

EU GMP

ICH Q7

Data Integrity (ALCOA++ principles)

Analytical Skills

Problem-solving Skills

Communication Skills

Educación

Bachelor’s degree in Pharmacy

Bachelor’s degree in Chemistry

Bachelor’s degree in Biotechnology

Bachelor’s degree in Life Sciences

Herramientas

Quality Management System (QMS)

GMP Documentation

Descripción del empleo

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.

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

• Ensure compliance with FDA 21 CFR Part 11 and EU GMP Annex 11 regarding electronic records and signatures.
• Manage controlled documents, records retention, and archiving processes.
• Assist in the review and approval of quality reports and metrics.
• Managing supplier compliance, including evaluation of change controls, variances, and supplier qualification reports.
• Ensuring compliance with General Prevention Standards, SOPs, and applicable risk assessments.

The QA System Technician will report to the QA System coordinator at Sant Celoni and be based on-site.

Candidate profile

Education & Experience :

Bachelor’s 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).

• Fluent English and native Spanish proficiency.
• Detail-oriented with strong documentation and compliance mindset
• Strong analytical and problem-solving skills.
• 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.
• Excellent communication skills (both written and verbal).
• Ability to work in cross-functional teams and manage multiple priorities.

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.