Quality Assurance specialist Oversight

HIPRA; Amer; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

HIPRA, a leading pharmaceutical and biotechnological company, is seeking a Quality Assurance Specialist Oversight in Amer, Spain. This role involves ensuring compliance with FDA regulations, overseeing QA processes, and implementing improvements in a dynamic environment. Join a multinational team dedicated to impactful projects in human health.

Servicios

Engage in impactful, long-term projects

Opportunities for training and development

Work in a multicultural environment

Formación

• At least 2 years of QA experience in the pharmaceutical or biotech sector.
• Experience with FDA processes and inspections is a plus.
• Willingness to work rotating shifts and in aseptic conditions.

Responsabilidades

• Participate in plant QA oversight concerning aseptic procedures and contamination risk control.
• Address gaps and improvements identified during FDA inspections.
• Supervise on-site processes in the Human Health area to ensure GMP compliance.

Conocimientos

Proactive

Flexible

Team-oriented

Ability to work under pressure

Proficient in English

Educación

Bachelor’s degree in biology, biotechnology, chemistry, pharmacy, or veterinary sciences

Descripción del empleo

Join to apply for the Quality Assurance Specialist Oversight role at HIPRA.

HIPRA is a pharmaceutical and biotechnological company focused on prevention and diagnosis for animal and human health, with a broad range of innovative vaccines and diagnostic services.

The company has a presence in over 40 countries, with subsidiaries, diagnostic centers, and production plants in Europe (Spain) and America (Brazil). Its core focus is Research and Development, investing 15% of its turnover into scientific advances for vaccine development, along with medical devices and traceability services.

We are seeking a motivated Quality Assurance Specialist Oversight for our offices in Amer (Girona) to support FDA inspections for Human Health projects.

Main Responsibilities

• Participate in plant QA oversight concerning aseptic procedures and contamination risk control, ensuring compliance with cGMP, company policies, procedures, and regulations.
• Address gaps and improvements identified during FDA inspections.

Qualifications

• Bachelor’s degree in biology, biotechnology, chemistry, pharmacy, or veterinary sciences.
• At least 2 years of QA experience in the pharmaceutical or biotech sector.
• Proactive, flexible, team-oriented, and able to work under pressure.
• Proficient in English, both written and spoken.
• Experience with FDA processes and inspections is a plus.
• Willingness to work rotating shifts and in aseptic conditions.

Functions

• Supervise on-site processes in the Human Health area to ensure GMP compliance and adherence to HIPRA's Quality System.
• Analyze processes, identify improvements, and implement corrective actions.
• Ensure proper investigation and documentation of deviations, root cause analysis, and implementation of CAPA.
• Monitor data and process indicators for process robustness and effectiveness of corrective measures.
• Train staff on GMP standards and participate in projects to improve quality and efficiency.

Reasons to Join HIPRA

• Engage in impactful, long-term projects to expand knowledge.
• Be part of a growing multinational with 40 subsidiaries worldwide.
• Work in a multicultural environment with opportunities for training and development.