ABOUT US

We are dedicated to the research, development, manufacture and distribution of allergen immunotherapy products, contributing to improving the quality of life of patients worldwide through innovative healthcare solutions.

Our Technical, R&D; and Clinical Trials headquarters are located in Zamudio, where our manufacturing site is also based. As part of our growth and expansion plans, we are looking for talented professionals committed to quality, innovation and continuous improvement.

Our values:

- PEOPLE-CENTRIC: We put people at the centre of everything we do.
- SELF-DEMANDING PEOPLE: We encourage individual accountability and high standards in pursuit of shared success.
- CURIOUS PEOPLE: We continuously learn and innovate, valuing the unique experience and perspectives that each person brings to the organisation.

ABOUT THE JOB

We are looking for a Quality Assurance & Pharmacovigilance Technician (UGC / LCPPV) to join our team in Zamudio, combining responsibilities in Pharmaceutical Quality Assurance (50%) and Local Pharmacovigilance (50%).

The successful candidate will work within the Quality Assurance and Pharmacovigilance functions, reporting to the Head of the Quality Assurance Unit for Quality Assurance activities and functionally to the EU Qualified Person for Pharmacovigilance (EU-QPPV) for Pharmacovigilance activities.

The position offers the opportunity to develop professionally in two complementary areas of pharmaceutical compliance, contributing to product quality, patient safety and regulatory compliance within a regulated pharmaceutical manufacturing environment.

MISSION

To contribute to the implementation, maintenance and continuous improvement of ROXALL's Pharmaceutical Quality System (PQS),



ensuring compliance with applicable GMP requirements, internal procedures and regulatory standards.

Additionally, to act as the Local Pharmacovigilance Contact Person in Spain, supporting the company's Pharmacovigilance System and ensuring the appropriate collection, documentation, communication and follow-up of medicinal product safety information in accordance with applicable European and Spanish pharmacovigilance requirements.

The position combines pharmaceutical quality oversight with local pharmacovigilance coordination, promoting effective collaboration between Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs and the EU-QPPV.

MAIN TASKS AND RESPONSIBILITIES

1. QUALITY ASSURANCE (50%)

- Pharmaceutical Quality System (PQS): Prepare, review, update and manage documentation associated with the Pharmaceutical Quality System, including Standard Operating Procedures (SOPs), quality manuals, risk management documentation and Product Quality Reviews (PQRs).
- GMP Documentation Review: Review and approve GMP documentation, including SOPs, validation and qualification protocols, technical reports, stability documentation and other controlled records, in accordance with established responsibilities and procedures.
- Batch Documentation: Review manufacturing and Quality Control batch documentation to support batch disposition and product release processes.




- Quality Events Management: Participate in the management and investigation of deviations, complaints, Change Controls, product recalls and Corrective and Preventive Actions (CAPAs), ensuring appropriate documentation, follow-up and closure.
- Audits and Supplier Qualification: Participate in internal audits, supplier audits, supplier qualification and approval activities, contributing to the identification and implementation of quality improvements.
- GMP Training: Participate in the preparation, delivery and monitoring of GMP training activities, promoting compliance with pharmaceutical quality requirements across the organisation.
- Continuous Improvement: Collaborate with the Head of the Quality Assurance Unit and other departments to identify improvement opportunities, strengthen quality risk management and maintain the effectiveness of the Pharmaceutical Quality System.

2. LOCAL PHARMACOVIGILANCE (50%)

- Local Pharmacovigilance Operations: Act as the local pharmacovigilance contact person in Spain, supporting the implementation and maintenance of the company's Pharmacovigilance System.
- Adverse Event Management: Ensure the appropriate collection, documentation, processing and timely communication of adverse events, special situations and other medicinal product safety information, including Individual Case Safety Reports (ICSRs).
- EU-QPPV Coordination: Maintain effective communication with the EU Qualified Person for Pharmacovigilance, escalating significant safety concerns, supporting signal management activities and contributing local information required for Pharmacovigilance System Master File (PSMF) maintenance.
- Regulatory Comp

📌 Quality Assurance (Bilbao)
🏢 Roxall Medicina España
📍 Bilbao