Quality Assurance & Pharmacovigilance Specialist — Spain

ROXALL Medicina España; Zamudio; On-site; EUR 42,000 - 62,000; Full time

Benefits offered by this job

Competitive compensation

Full-time Zamudio (Bizkaia)

Professional development

Collaborative environment

Job summary

ROXALL Medicina España in Zamudio (Bizkaia) seeks a Quality Assurance & Pharmacovigilance Technician to support the Pharmaceutical Quality System and local pharmacovigilance, reporting to the Head of QA Unit and functionally to the EU-QPPV. The role blends QA oversight with safety reporting to ensure patient safety and regulatory compliance.

You will work across QA, QC, Manufacturing and Regulatory Affairs, contributing to continuous improvement, CAPAs and regulatory submissions while ensuring

Qualifications

• University degree in Pharmacy, Biology, Biochemistry, Biotechnology, Chemistry, Health Sciences or a related scientific discipline.
• Formal training in Pharmaceutical Quality Systems, Quality Assurance, Pharmacovigilance, Drug Safety or Regulatory Affairs.
• At least 3 years of relevant professional experience in pharmaceutical QA, Pharmacovigilance, Drug Safety, Regulatory Affairs or related regulated pharmaceutical activities.
• Experience working under EU GMP requirements and within pharmaceutical quality systems.
• Experience preparing, reviewing or managing GMP documentation, SOPs, technical records and quality reports.
• 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.

Responsibilities

• Oversee the Pharmaceutical Quality System (PQS) and review GMP documentation and batch records.
• Coordinate local pharmacovigilance operations and ensure timely adverse event reporting.
• Maintain liaison with the EU-QPPV and support Pharmacovigilance System Master File updates.
• Support regulatory compliance with European and Spanish pharmacovigilance rules.
• Interact with regulatory authorities and support inspections and audits.
• Participate in risk management and CAPA processes; ensure proper documentation.
• Collaborate across Quality Assurance, Quality Control, Manufacturing and Regulatory Affairs.
• Contribute to continuous improvement and quality culture in the site.

Skills

Fluent English

Analytical skills

Cross-functional collaboration

Organisational skills

Communication skills

Education

University degree in Pharmacy, Biology, Biochemistry, Biotechnology, Chemistry, Health Sciences or related discipline

Job description

ROXALL Medicina España in Zamudio (Bizkaia) seeks a Quality Assurance & Pharmacovigilance Technician to support the Pharmaceutical Quality System and local pharmacovigilance, reporting to the Head of QA Unit and functionally to the EU-QPPV. The role blends QA oversight with safety reporting to ensure patient safety and regulatory compliance.

You will work across QA, QC, Manufacturing and Regulatory Affairs, contributing to continuous improvement, CAPAs and regulatory submissions while ensuring