Quality Assurance Specialist Oversight

buscojobs España; Cádiz; Presencial; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

Une entreprise pharmaceutique en pleine expansion, HIPRA, recherche un Spécialiste en Assurance Qualité pour soutenir les projets d'inspection FDA pour la santé humaine. Le rôle implique la supervision des processus sur site en garantissant la conformité avec les réglementations, tout en participant à des projets d'amélioration continue et de formation. Ce poste s'adresse à un professionnel proactif et flexible, avec une expérience en assurance qualité et des compétences solides en anglais.

Servicios

Opportunités de formation et développement professionnel

Environnement de travail multiculturel

Projets impliquants à long terme

Formación

• Au moins 2 ans d'expérience en assurance qualité dans le secteur pharmaceutique ou biopharmaceutique.
• Expérience avec les processus et inspections de la FDA est un plus.
• Capacité à travailler dans des conditions aseptiques.

Responsabilidades

• Superviser les processus sur site relatifs aux produits de santé humaine pour garantir la conformité.
• Montrer des données critiques et des indicateurs de processus pour assurer l'efficacité.

Conocimientos

Proactivité

Flexibilité

Travail d'équipe

Gestion du stress

Compétences en anglais

Educación

Licence en biologie, biotechnologie, chimie, pharmacie ou sciences vétérinaires

Descripción del empleo

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

HIPRA has a solid international presence in more than 40 countries, with its own subsidiaries, 11 diagnostic centres, and 6 production plants strategically located in Europe (Spain) and America (Brazil).

Research and Development constitute the core of its knowledge. HIPRA dedicates 15% of its annual turnover to R&D activities that concentrate on the creation and application of the latest scientific advances to develop high-quality innovative vaccines. The company also develops medical devices and traceability services to add value to its vaccination experience.

We are currently looking for a motivated Quality Assurance Specialist - Oversight for our offices in Amer, Girona, to join our team and support FDA Inspection for Human Health projects .

Main Responsibilities :

• Actively participate in plant QA oversight regarding aseptic behavior and contamination risk control, ensuring activities comply with cGMP, corporate policy, local procedures, and regulatory expectations.
• Address gaps and implement improvements identified across the organization for FDA inspections.

Qualifications :

• Bachelor's degree in biology, biotechnology, chemistry, pharmacy, or veterinary sciences.
• Minimum of 2 years of experience in Quality Assurance within the pharmaceutical or biotechnological sector.
• Proactive, flexible, and eager to contribute in a fast-paced, evolving environment. Team player and able to work under pressure.
• Proficient in written and spoken English.
• Experience with FDA processes and inspections is a plus.
• Willingness to work on rotating morning and afternoon shifts and in aseptic conditions.

Functions :

• Supervise on-site processes related to products in the Human Health area to ensure compliance with GMP and HIPRA's Quality System.
• Analyze processes and work methods to identify improvements and prevent deviations.
• Implement corrective and preventive actions to resolve non-compliances and improve processes.
• Ensure proper investigation and documentation of deviations, with root cause analysis and corrective actions.
• Monitor critical data and process indicators to ensure process robustness and effectiveness of measures.
• Ensure staff training on GMP and participate in training delivery as needed.
• Propose and implement ideas for improvement and innovation.
• Contribute to departmental projects with ideas and proposals.

Reasons to Join HIPRA :

• Involvement in relevant, long-term projects to expand knowledge and experience.
• Growing multinational company with 40 subsidiaries worldwide.
• Multicultural environment fostering teamwork.
• Opportunities for training and professional development.
• Equal opportunity employment policy, considering all qualified applicants without discrimination.

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