Quality Assurance Manager
il y a 1 jour
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.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 ensuring 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).Personal skills: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.For more information on how we process your personal data, please visit our privacy statement. #J-18808-Ljbffr
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