Quality Assurance & Pharmacovigilance Technician

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 Compliance: Support compliance with applicable European and Spanish pharmacovigilance legislation, Good Pharmacovigilance Practices (GVP) and internal procedures.
• Regulatory Authority Interactions: Act as a local contact point for pharmacovigilance matters, supporting communications with AEMPS and other competent authorities, regulatory requests, inspections and audits.
• Risk Management: Participate in the local implementation and monitoring of Risk Management Plans (RMPs), risk minimisation measures and safety communications.
• Pharmacovigilance Quality System: Prepare, review and maintain local pharmacovigilance SOPs and working instructions, participating in deviation management, CAPAs, Change Controls and compliance monitoring.
• Vendor and Partner Oversight: Support pharmacovigilance agreements, safety data exchange activities and oversight of distributors, service providers and other relevant partners.
• Pharmacovigilance Training: Coordinate and monitor initial and periodic pharmacovigilance training, maintaining appropriate training records and promoting safety awareness throughout the organisation.
• Cross-functional Collaboration: Collaborate with Quality Assurance, Quality Control, Manufacturing and Regulatory Affairs in the assessment and management of product quality complaints, defects, recalls and other issues potentially affecting patient safety.

REQUIREMENTS

Education & Technical Background

• University degree in Pharmacy, Biology, Biochemistry, Biotechnology, Chemistry, Health Sciences or a related scientific discipline.
• Additional formal training in Pharmaceutical Quality Systems, Quality Assurance, Pharmacovigilance, Drug Safety or Regulatory Affairs.
• At least 3 years of relevant professional experience in pharmaceutical Quality Assurance, Pharmacovigilance, Drug Safety, Regulatory Affairs or related regulated pharmaceutical activities.
• Professional experience working under EU GMP requirements and within pharmaceutical quality systems.
• Experience preparing, reviewing or managing GMP documentation, SOPs, technical records and quality reports.
• Practical knowledge of deviations, CAPAs, Change Controls, complaints and quality risk management.
• Knowledge of European pharmacovigilance legislation and Good Pharmacovigilance Practices (GVP).
• Knowledge of adverse event reporting and pharmacovigilance processes.
• Ability to work effectively across multidisciplinary technical, quality and regulatory teams.

Desirable Experience & Knowledge

• Previous professional experience combining Quality Assurance and Pharmacovigilance responsibilities.
• Experience within a pharmaceutical manufacturer and/or Marketing Authorisation Holder (MAH).
• Experience in the management of Individual Case Safety Reports (ICSRs).
• Knowledge of MedDRA terminology, Risk Management Plans (RMPs), signal management and Pharmacovigilance Agreements (PVAs).
• Experience supporting GMP and/or pharmacovigilance inspections and audits.
• Experience with supplier qualification, Product Quality Reviews (PQRs) and batch documentation review.
• Familiarity with pharmacovigilance safety databases such as Argus, ArisG, Veeva Safety or equivalent systems.
• Experience with biological medicinal products, vaccines, allergens or allergen immunotherapy products.

Skills & Languages

• Fluent English, both written and spoken (minimum C1 level or equivalent).
• Advanced computer skills and confidence working in digital and regulated environments.
• Strong analytical skills and attention to detail.
• Ability to interpret scientific, technical and regulatory information.
• Strong organisational skills and ability to manage competing priorities and deadlines.
• Ability to work autonomously, maintaining a structured, rigorous and solution-oriented approach.
• Strong communication and cross-functional collaboration skills.
• High commitment to quality, patient safety, confidentiality and regulatory compliance.
• A high level of corporate competencies, ideally above the organisation's average range (80th percentile desirable), will be particularly valued.

REMUNERATION & WHAT WE OFFER

• Competitive compensation package based on experience, qualifications and responsibilities.
• Full-time position based in Zamudio (Bizkaia).
• Opportunity to develop professionally in two complementary areas: Pharmaceutical Quality Assurance and Pharmacovigilance.
• Direct involvement in the maintenance and continuous improvement of the Pharmaceutical Quality System.
• Participation in local pharmacovigilance activities and collaboration with the EU-QPPV.
• Exposure to GMP and GVP regulatory frameworks within a pharmaceutical manufacturing and Marketing Authorisation Holder environment.
• Participation in cross-functional activities involving Quality Assurance, Quality Control, Manufacturing and Regulatory Affairs.
• Opportunity to contribute directly to pharmaceutical quality, regulatory compliance and patient safety.
• Professional development within a growing, science-driven organisation.
• Collaborative working environment focused on quality, innovation and continuous improvement.

PROFILE

We are looking for a rigorous, analytical and highly organised professional with experience in regulated pharmaceutical environments, who is motivated to develop a multidisciplinary career combining Quality Assurance and Pharmacovigilance.