Quality Assurance specialist Oversight

Hipra; Navarra; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical and biotechnological company is seeking a Quality Assurance Specialist - Oversight to join their team in Amer, Girona. In this role, you will ensure compliance with cGMP and support FDA inspections, playing a crucial part in maintaining high-quality standards. They offer a multicultural environment, opportunities for training, and involvement in long-term projects.

Servicios

Opportunities for training and professional development

Multicultural environment fostering teamwork

Formación

• Minimum 2 years of experience in Quality Assurance within the pharmaceutical or biotechnological sector.
• Proficient in written and spoken English.
• Experience with FDA processes and inspections is a plus.

Responsabilidades

• Participate in QA oversight regarding aseptic behavior and contamination risk control.
• Implement corrective and preventive actions for non-compliance issues.
• Ensure compliance with GMP and HIPRA's Quality System.

Conocimientos

Proactive

Flexibility

Team player

Communication

Educación

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

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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