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.
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