Quality Assurance Coordinator (ATX25-01)
As Quality Assurance Coordinator at AUROBAC, you will be responsible for implementing, monitoring and continuously improving the quality management system. You will play a key role in ensuring compliance with current regulations and in supporting the R&D teams in guaranteeing process conformity. The Quality Assurance Coordinator will report to the Quality and Regulatory Affairs Director and will work closely with all AUROBAC THERAPEUTICS teams.
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Missions
• Implementation of the quality approach in line with the company’s strategic priorities and regulatory requirements.
• Ensuring that the quality system (preclinical, clinical and CMC activities) complies with the applicable standards.
• Drawing up and implementing procedures for quality processes, and training and raising the awareness of teams.
• Supporting R&D teams in drafting operational procedures and coordinating their revision.
• Managing quality documentation and ensure data traceability.
• Conducting internal audits and helping to prepare for inspections by the regulatory authorities.
• Contributing to the selection, qualification and evaluation of subcontractors.
• Actively participating in the continuous improvement of processes and quality risk management.
• Participating in the monitoring of changes in standards and regulations.
Technical skills
• Knowledge of drug development stages.
• Knowledge of quality assurance standards (e.g. ISO 9001) and GxP regulations applicable to drug development in an international environment (e.g. GCP, GMP, GLP, GCLP).
• Good document management practices.
• Proficiency in audit techniques.
Personal skills
• Fluency in English is essential.
• Planning and anticipation.
• Excellent organizational, communication and analytical skills.
• Excellent writing skills.
• Ability to solve problems proactively, and adaptability.
• Ability to work both independently and cross-functionally (project mode).
Professional experience
• Training in pharmacy or higher science (Bac +5), with a specialization in quality assurance.
• First experience in managing a quality system in the pharmaceutical R&D sector (e.g. Biotech company, pharmaceutical laboratory, clinical CRO).
To apply, please send your CV and cover letter application in ENGLISH to jobs@aurobac-tx.com mentioning the reference ATX25-01.
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