Quality Assurance Specialist

hace 4 semanas


Madrid, Madrid, España TFS HealthScience A tiempo completo
Job Description

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.

The Quality Assurance Manager will support quality issue management and corrective and preventive actions (CAPA) management, ensuring compliance and driving continuous improvement across processes.

Key Responsibilities:

  • Maintain and approve quality issues and CAPAs in the electronic Quality Management System (eQMS).
  • Provide support to internal customers with records in quality issues and root cause/CAPA processes.
  • Contribute to improvements in the eQMS and ensure high-quality data metrics and KPIs.
  • Drive quality through proactive support, training, coaching, and consulting, adhering to quality by design principles.
  • Advise internal teams on addressing issues while ensuring compliance with global regulations and standard operating procedures.

Qualifications:

  • Extensive experience in Quality Assurance within the pharmaceutical/biotech industry or clinical development.
  • Proficient in managing deviations, quality issues, and CAPA processes.
  • Expertise in continuous improvement methodologies, including Lean Six Sigma.
  • In-depth knowledge of GCP regulations, ICH guidelines, and validation principles (e.g., GAMP5).
  • BASIC understanding of other GxP disciplines, such as GVP, GLP, GRP, and GMP.
  • Strong understanding of QA principles, risk management, and regulatory frameworks.
  • Experience with computerized system development.
  • Fluent in English with excellent communication, problem-solving, and organizational skills.
  • High learning agility, self-motivated, and team-oriented with intercultural awareness.
Salary Information

We offer a competitive salary range of $120,000 - $180,000 per annum, depending on qualifications and experience.

About TFS HealthScience

Founded over 27 years ago in Lund, Sweden, TFS HealthScience is a global Contract Research Organization.

With more than 800 professionals across 40 countries, we offer flexible, solution-driven clinical research services in key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide us in creating a unified, innovative, and collaborative culture, driving us towards a healthier future.



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