Quality Assurance Coordinator

il y a 2 jours

Lyon e, France AUROBAC THERAPEUTICS Temps plein

**PRESENTATION OF THE COMPANY**

AUROBAC THERAPEUTICS is a fast-growing biopharmaceutical company founded in 2022 by a consortium of three companies: Boehringer Ingelheim, Evotec and bioMérieux.

Our company aims to accelerate the development of innovative therapies for infectious diseases through preclinical, clinical and CMC research and development (R&D) programmes. It is in this dynamic and highly technological environment that we are looking to strengthen our team by recruiting a Quality Assurance Coordinator.

**DESCRIPTION**

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 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)..

**Job Types**: Full-time, Permanent
Status: Cadre

Pay: 40,000.00€ - 80,000.00€ per year

**Education**:

- Master's (required)

**Experience**:

- quality documentation system in the pharmaceutical R&D: 1 year (required)

**Language**:

- English (required)

Work Location: In person

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